Trial Outcomes & Findings for A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030) (NCT NCT03449147)
NCT ID: NCT03449147
Last Updated: 2021-09-02
Results Overview
24-hour coughs per hour was defined as the average hourly cough frequency based on 24-hour sound recordings using a digital recording device (cough monitor). A longitudinal analysis of covariance (ANCOVA) model was applied to log-transformed cough data to determine geometric mean (GM) 24-hour coughs per hour at baseline and week 24. The GMR (Week 24 GM 24-hour coughs per hour divided by Baseline GM 24-hour coughs per hour) is reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1317 participants
Primary outcome timeframe
Baseline, Week 24
Results posted on
2021-09-02
Participant Flow
1317 participants were randomized to the 52-week treatment period, and 1314 participants received at least 1 dose of study intervention. After the main study, 122 participants continued in an optional Off-Treatment observational study period (no treatment).
Participant milestones
| Measure |
Placebo
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period.
|
Gefapixant 15 mg BID
Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 24-week main study period and 28-week extension period.
|
Gefapixant 45 mg BID
Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and 28-week extension period.
|
|---|---|---|---|
|
52-week Treatment Period
STARTED
|
436
|
442
|
439
|
|
52-week Treatment Period
COMPLETED
|
382
|
368
|
355
|
|
52-week Treatment Period
NOT COMPLETED
|
54
|
74
|
84
|
|
12-Week Off-Treatment Durability Period
STARTED
|
48
|
37
|
37
|
|
12-Week Off-Treatment Durability Period
COMPLETED
|
47
|
36
|
37
|
|
12-Week Off-Treatment Durability Period
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period.
|
Gefapixant 15 mg BID
Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 24-week main study period and 28-week extension period.
|
Gefapixant 45 mg BID
Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and 28-week extension period.
|
|---|---|---|---|
|
52-week Treatment Period
Death
|
0
|
1
|
0
|
|
52-week Treatment Period
Lost to Follow-up
|
6
|
2
|
5
|
|
52-week Treatment Period
Other
|
0
|
1
|
2
|
|
52-week Treatment Period
Physician Decision
|
1
|
0
|
3
|
|
52-week Treatment Period
Screen Failure
|
1
|
2
|
0
|
|
52-week Treatment Period
Withdrawal by Subject
|
46
|
68
|
74
|
|
12-Week Off-Treatment Durability Period
Withdrawal by Subject
|
1
|
0
|
0
|
|
12-Week Off-Treatment Durability Period
Other
|
0
|
1
|
0
|
Baseline Characteristics
All participants with 24-hour coughs per hour data available at baseline
Baseline characteristics by cohort
| Measure |
Placebo
n=436 Participants
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period.
|
Gefapixant 15 mg BID
n=442 Participants
Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 24-week main study period and 28-week extension period.
|
Gefapixant 45 mg BID
n=439 Participants
Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and 28-week extension period.
|
Total
n=1317 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.4 Years
STANDARD_DEVIATION 12.5 • n=436 Participants
|
58.4 Years
STANDARD_DEVIATION 11.3 • n=442 Participants
|
57.8 Years
STANDARD_DEVIATION 12.4 • n=439 Participants
|
58.2 Years
STANDARD_DEVIATION 12.1 • n=1317 Participants
|
|
Sex: Female, Male
Female
|
326 Participants
n=436 Participants
|
331 Participants
n=442 Participants
|
329 Participants
n=439 Participants
|
986 Participants
n=1317 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=436 Participants
|
111 Participants
n=442 Participants
|
110 Participants
n=439 Participants
|
331 Participants
n=1317 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
85 Participants
n=436 Participants
|
93 Participants
n=442 Participants
|
89 Participants
n=439 Participants
|
267 Participants
n=1317 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
348 Participants
n=436 Participants
|
347 Participants
n=442 Participants
|
344 Participants
n=439 Participants
|
1039 Participants
n=1317 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=436 Participants
|
2 Participants
n=442 Participants
|
6 Participants
n=439 Participants
|
11 Participants
n=1317 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
20 Participants
n=436 Participants
|
28 Participants
n=442 Participants
|
24 Participants
n=439 Participants
|
72 Participants
n=1317 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=436 Participants
|
14 Participants
n=442 Participants
|
15 Participants
n=439 Participants
|
44 Participants
n=1317 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=436 Participants
|
2 Participants
n=442 Participants
|
3 Participants
n=439 Participants
|
9 Participants
n=1317 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=436 Participants
|
9 Participants
n=442 Participants
|
14 Participants
n=439 Participants
|
28 Participants
n=1317 Participants
|
|
Race (NIH/OMB)
White
|
356 Participants
n=436 Participants
|
358 Participants
n=442 Participants
|
346 Participants
n=439 Participants
|
1060 Participants
n=1317 Participants
|
|
Race (NIH/OMB)
More than one race
|
36 Participants
n=436 Participants
|
31 Participants
n=442 Participants
|
37 Participants
n=439 Participants
|
104 Participants
n=1317 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=436 Participants
|
0 Participants
n=442 Participants
|
0 Participants
n=439 Participants
|
0 Participants
n=1317 Participants
|
|
Baseline 24-Hour Coughs Per Hour
|
27.45 Coughs/Hour
STANDARD_DEVIATION 24.44 • n=432 Participants • All participants with 24-hour coughs per hour data available at baseline
|
26.82 Coughs/Hour
STANDARD_DEVIATION 21.25 • n=431 Participants • All participants with 24-hour coughs per hour data available at baseline
|
26.84 Coughs/Hour
STANDARD_DEVIATION 27.04 • n=434 Participants • All participants with 24-hour coughs per hour data available at baseline
|
27.04 Coughs/Hour
STANDARD_DEVIATION 24.35 • n=1297 Participants • All participants with 24-hour coughs per hour data available at baseline
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants who took at least 1 dose of study intervention, had available 24-hour cough data at baseline and at least one available post-baseline measurement during the treatment period.
24-hour coughs per hour was defined as the average hourly cough frequency based on 24-hour sound recordings using a digital recording device (cough monitor). A longitudinal analysis of covariance (ANCOVA) model was applied to log-transformed cough data to determine geometric mean (GM) 24-hour coughs per hour at baseline and week 24. The GMR (Week 24 GM 24-hour coughs per hour divided by Baseline GM 24-hour coughs per hour) is reported.
Outcome measures
| Measure |
Placebo
n=419 Participants
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period.
|
Gefapixant 15 mg BID
n=415 Participants
Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 24-week main study period and 28-week extension period.
|
Gefapixant 45 mg BID
n=409 Participants
Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and 28-week extension period.
|
|---|---|---|---|
|
Model-Based Geometric Mean Ratio (GMR) of 24-Hour Coughs Per Hour at Week 24/Baseline
|
0.43 Ratio
Interval 0.39 to 0.48
|
0.43 Ratio
Interval 0.38 to 0.47
|
0.37 Ratio
Interval 0.33 to 0.41
|
PRIMARY outcome
Timeframe: Up to 54 WeeksPopulation: All randomized participants who received at least one dose of study intervention during the 52-week treatment period. Per protocol, participants in the optional off-treatment observational period were not included. 3 participants randomized to placebo group who took 1 or more incorrect dose(s) of study drug were counted in the higher dose group of gefapixant received: 2 participants were analyzed in the gefapixant 15 mg group and 1 was analyzed in the gefapixant 45 mg group.
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.
Outcome measures
| Measure |
Placebo
n=432 Participants
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period.
|
Gefapixant 15 mg BID
n=442 Participants
Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 24-week main study period and 28-week extension period.
|
Gefapixant 45 mg BID
n=440 Participants
Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and 28-week extension period.
|
|---|---|---|---|
|
Number of Participants Who Experienced At Least One Adverse Event (AE) During Treatment and Follow-up
|
349 Participants
|
373 Participants
|
399 Participants
|
PRIMARY outcome
Timeframe: Up to 52 weeksPopulation: All randomized participants who received at least one dose of study intervention during the 52-week treatment period. Per protocol, participants in the optional off-treatment observational period were not included. 3 participants randomized to placebo group who took 1 or more incorrect dose(s) of study drug were counted in the higher dose group of gefapixant received: 2 participants were analyzed in the gefapixant 15 mg group and 1 was analyzed in the gefapixant 45 mg group.
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.
Outcome measures
| Measure |
Placebo
n=432 Participants
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period.
|
Gefapixant 15 mg BID
n=442 Participants
Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 24-week main study period and 28-week extension period.
|
Gefapixant 45 mg BID
n=440 Participants
Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and 28-week extension period.
|
|---|---|---|---|
|
Number of Participants Who Discontinued a Study Drug Due to an AE
|
25 Participants
|
40 Participants
|
100 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants who took at least 1 dose of study intervention, had available awake 24-hour cough data at baseline and at least one available post-baseline measurement during the treatment period.
Awake coughs per hour was defined as the average hourly cough frequency while the participant is awake, based on a 24-hour interval of sound recordings using a digital recording device (cough monitor). ANCOVA model was applied to log-transformed cough data to determine GM of awake coughs per hour at baseline and week 24. The GMR (Week 24 GM awake coughs per hour divided by Baseline GM awake coughs per hour) is reported.
Outcome measures
| Measure |
Placebo
n=419 Participants
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period.
|
Gefapixant 15 mg BID
n=415 Participants
Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 24-week main study period and 28-week extension period.
|
Gefapixant 45 mg BID
n=409 Participants
Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and 28-week extension period.
|
|---|---|---|---|
|
Model-Based GMR of Awake Coughs Per Hour at Week 24/Baseline
|
0.42 Ratio
Interval 0.38 to 0.47
|
0.41 Ratio
Interval 0.37 to 0.46
|
0.36 Ratio
Interval 0.32 to 0.4
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants who had taken at least 1 dose of study intervention, had available LCQ data at baseline, and at least one available post-baseline measurement in the treatment period.
The 19-item LCQ assessed the impact of chronic cough in three health-related quality of life (HRQoL) domains (physical, social and psychological). The LCQ is calculated as a mean score for each domain ranging from 1 to 7, with a total score ranging from 3 to 21. 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 Week 24. The percentage of participants (logistic regression model-based) with a ≥1.3-point increase in the LCQ total score at Week 24 is presented.
Outcome measures
| Measure |
Placebo
n=406 Participants
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period.
|
Gefapixant 15 mg BID
n=404 Participants
Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 24-week main study period and 28-week extension period.
|
Gefapixant 45 mg BID
n=399 Participants
Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and 28-week extension period.
|
|---|---|---|---|
|
Percentage of Participants With a ≥1.3 Point Change From Baseline in the Leicester Questionnaire (LCQ) Total Score at Week 24
|
70.1 Percentage of Participants
|
75.9 Percentage of Participants
|
76.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants who took at least 1 dose of study intervention, had available 24-hour cough data at baseline and at least one available post-baseline measurement in the treatment period.
24-hour coughs per hour was defined as the average hourly cough frequency based on 24-hour sound recordings using a digital recording device (cough monitor). A clinically meaningful improvement from baseline is defined as a ≤-30% change (≥30% reduction) in 24-hour coughs per hour at week 24. The percentage of participants (logistic regression model-based) with a ≤ -30% change from baseline in 24-hour coughs per hour at Week 24 (≥30% reduction from baseline) is presented.
Outcome measures
| Measure |
Placebo
n=419 Participants
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period.
|
Gefapixant 15 mg BID
n=415 Participants
Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 24-week main study period and 28-week extension period.
|
Gefapixant 45 mg BID
n=409 Participants
Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and 28-week extension period.
|
|---|---|---|---|
|
Percentage of Participants With a ≤-30% Change From Baseline in 24-hour Coughs Per Hour at Week 24
|
66.9 Percentage of Participants
|
67.4 Percentage of Participants
|
72.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants who had taken at least 1 dose of study intervention, had available CSD data at baseline, and at least one available post-baseline measurement in the treatment period.
The 7-item CSD was used to record participants' daily cough frequency, cough intensity, and disruption due to cough. Each item was rated on an 11-point scale ranging from 0 (best) to 10 (worst); the total daily CSD score was the sum of these seven item scores (Min=0, Max=70). Mean weekly CSD total score was defined as the average of the mean total daily scores collected during the week prior to each visit. The percentage of participants (logistic regression model-based) with a ≤-1.3 point change from baseline in CSD at Week 24 (or ≥1.3 point reduction from baseline) is reported.
Outcome measures
| Measure |
Placebo
n=428 Participants
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period.
|
Gefapixant 15 mg BID
n=426 Participants
Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 24-week main study period and 28-week extension period.
|
Gefapixant 45 mg BID
n=425 Participants
Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and 28-week extension period.
|
|---|---|---|---|
|
Percentage of Participants With ≤-1.3 Point Change From Baseline of Mean Weekly Cough Severity Diary (CSD) Total Score at Week 24
|
69.1 Percentage of Participants
|
74.8 Percentage of Participants
|
77.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants who had taken at least 1 dose of study intervention, had available CSD data at baseline, and at least one available post-baseline measurement in the treatment period.
The 7-item CSD was used to record participants' daily cough frequency, cough intensity, and disruption due to cough. Each item was rated on an 11-point scale ranging from 0 (best) to 10 (worst); the total daily CSD score was the sum of these seven item scores (Min=0, Max=70). Mean weekly CSD total score was defined as the average of the mean total daily scores collected during the week prior to each visit. The percentage of participants (logistic regression model-based) with a ≤-2.7 point change from baseline in CSD at Week 24 (or ≥2.7 point reduction from baseline) is reported.
Outcome measures
| Measure |
Placebo
n=428 Participants
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period.
|
Gefapixant 15 mg BID
n=426 Participants
Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 24-week main study period and 28-week extension period.
|
Gefapixant 45 mg BID
n=425 Participants
Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and 28-week extension period.
|
|---|---|---|---|
|
Percentage of Participants With ≤-2.7 Point Change From Baseline of Mean Weekly CSD Total Score at Week 24
|
41.0 Percentage of Participants
|
46.6 Percentage of Participants
|
55.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants who had taken at least 1 dose of study intervention, had available VAS data at baseline, and at least one available post-baseline measurement in the treatment period.
The VAS is a single-item questionnaire with the response on a 100- point scale ranging from 0 ("No Cough") to 100 ("Extremely Severe Cough"). Mean weekly VAS score was defined as the average of the VAS scores collected during the week prior to each visit. The percentage of participants (logistic regression model-based) with a ≤-30 mm change from baseline in cough severity VAS score at Week 24 is reported.
Outcome measures
| Measure |
Placebo
n=428 Participants
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period.
|
Gefapixant 15 mg BID
n=426 Participants
Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 24-week main study period and 28-week extension period.
|
Gefapixant 45 mg BID
n=425 Participants
Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and 28-week extension period.
|
|---|---|---|---|
|
Percentage of Participants With a ≤-30 Millimeter (mm) Change From Baseline in Cough Severity Visual Analog Scale (VAS) Score at Week 24
|
40.9 Percentage of participants
|
51.4 Percentage of participants
|
53.3 Percentage of participants
|
Adverse Events
Placebo
Serious events: 25 serious events
Other events: 248 other events
Deaths: 0 deaths
Gefapixant 15 mg BID
Serious events: 24 serious events
Other events: 290 other events
Deaths: 1 deaths
Gefapixant 45 mg BID
Serious events: 25 serious events
Other events: 359 other events
Deaths: 0 deaths
Placebo: Off Tx
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Gefapixant 15 mg BID: Off Tx
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Gefapixant 45 mg BID: Off Tx
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=432 participants at risk
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period.
|
Gefapixant 15 mg BID
n=442 participants at risk
Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 24-week main study period and 28-week extension period.
|
Gefapixant 45 mg BID
n=440 participants at risk
Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and 28-week extension period.
|
Placebo: Off Tx
n=48 participants at risk
Participants previously treated with dose-matched placebo BID for 52 weeks during the main study and extension study periods were observed for up to 3 months during an optional Off-Treatment Durability study period (participants received no treatment).
|
Gefapixant 15 mg BID: Off Tx
n=37 participants at risk
Participants previously treated with gefapixant 15 mg BID for 52 weeks during the main study and extension study periods were observed for up to 3 months during an optional Off-Treatment Durability study period (participants received no treatment).
|
Gefapixant 45 mg BID: Off Tx
n=37 participants at risk
Participants previously treated with gefapixant BID for 52 weeks during the main study and extension study periods were observed for up to 3 months during an optional Off-Treatment Durability study period (participants received no treatment).
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/440 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
2.7%
1/37 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/440 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/442 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Cardiac disorders
Myocardial infarction
|
0.23%
1/432 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/440 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Congenital, familial and genetic disorders
Congenital choroid plexus cyst
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/442 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Eye disorders
Cataract
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/440 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/442 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Gastrointestinal disorders
Gastritis
|
0.46%
2/432 • Number of events 2 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/440 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/442 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
General disorders
Pyrexia
|
0.23%
1/432 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/442 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Infections and infestations
Bronchitis
|
0.23%
1/432 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Infections and infestations
COVID-19 pneumonia
|
0.23%
1/432 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Infections and infestations
Chronic tonsillitis
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/442 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Infections and infestations
Diverticulitis
|
0.23%
1/432 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Infections and infestations
Gastroenteritis
|
0.23%
1/432 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Infections and infestations
Influenza
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.45%
2/442 • Number of events 2 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Infections and infestations
Lung abscess
|
0.23%
1/432 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/440 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.68%
3/442 • Number of events 3 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/440 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/442 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Infections and infestations
Respiratory tract infection
|
0.23%
1/432 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Infections and infestations
Tonsillitis bacterial
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/440 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.23%
1/432 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/440 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Infections and infestations
Urosepsis
|
0.46%
2/432 • Number of events 2 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Infections and infestations
Vulval abscess
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/440 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/442 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.23%
1/432 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/440 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Injury, poisoning and procedural complications
Disinfectant poisoning
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/440 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/442 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/440 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.23%
1/432 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.23%
1/432 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/440 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/440 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.23%
1/432 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/440 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/440 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/442 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/442 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/442 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.23%
1/432 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/440 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/440 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.23%
1/432 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/442 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/440 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/442 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/442 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
|
0.23%
1/432 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal meningioma benign
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/440 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/442 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/442 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/442 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.23%
1/432 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Nervous system disorders
Migraine
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/442 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/440 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Nervous system disorders
Syncope
|
0.23%
1/432 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/442 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Psychiatric disorders
Confusional state
|
0.23%
1/432 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Psychiatric disorders
Stress
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/442 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Psychiatric disorders
Suicide attempt
|
0.23%
1/432 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/440 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/442 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.23%
1/432 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/442 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/440 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.23%
1/432 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/440 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.23%
1/432 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.46%
2/432 • Number of events 2 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/442 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/440 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.23%
1/432 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Vascular disorders
Aortic dissection
|
0.23%
1/432 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/442 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/440 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/432 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/442 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.23%
1/440 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
Other adverse events
| Measure |
Placebo
n=432 participants at risk
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period.
|
Gefapixant 15 mg BID
n=442 participants at risk
Participants received a gefapixant 15 mg tablet and placebo tablet to match gefapixant 45 mg BID during the 24-week main study period and 28-week extension period.
|
Gefapixant 45 mg BID
n=440 participants at risk
Participants received a gefapixant 45 mg tablet and placebo tablet to match gefapixant 15 mg BID during the 24-week main study period and 28-week extension period.
|
Placebo: Off Tx
n=48 participants at risk
Participants previously treated with dose-matched placebo BID for 52 weeks during the main study and extension study periods were observed for up to 3 months during an optional Off-Treatment Durability study period (participants received no treatment).
|
Gefapixant 15 mg BID: Off Tx
n=37 participants at risk
Participants previously treated with gefapixant 15 mg BID for 52 weeks during the main study and extension study periods were observed for up to 3 months during an optional Off-Treatment Durability study period (participants received no treatment).
|
Gefapixant 45 mg BID: Off Tx
n=37 participants at risk
Participants previously treated with gefapixant BID for 52 weeks during the main study and extension study periods were observed for up to 3 months during an optional Off-Treatment Durability study period (participants received no treatment).
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
18/432 • Number of events 20 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
6.1%
27/442 • Number of events 29 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
6.1%
27/440 • Number of events 34 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Gastrointestinal disorders
Dry mouth
|
2.5%
11/432 • Number of events 12 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
3.4%
15/442 • Number of events 15 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
7.3%
32/440 • Number of events 34 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Gastrointestinal disorders
Nausea
|
7.4%
32/432 • Number of events 42 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
5.9%
26/442 • Number of events 33 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
10.7%
47/440 • Number of events 57 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Infections and infestations
Bronchitis
|
5.3%
23/432 • Number of events 27 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
4.5%
20/442 • Number of events 24 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
4.1%
18/440 • Number of events 19 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
4.2%
2/48 • Number of events 2 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Infections and infestations
Influenza
|
8.1%
35/432 • Number of events 45 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
6.6%
29/442 • Number of events 35 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
5.5%
24/440 • Number of events 27 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Infections and infestations
Nasopharyngitis
|
16.2%
70/432 • Number of events 101 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
21.0%
93/442 • Number of events 128 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
15.9%
70/440 • Number of events 95 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
4.2%
2/48 • Number of events 2 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Infections and infestations
Sinusitis
|
4.2%
18/432 • Number of events 20 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
5.2%
23/442 • Number of events 25 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
3.2%
14/440 • Number of events 16 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
2.1%
1/48 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Infections and infestations
Upper respiratory tract infection
|
6.0%
26/432 • Number of events 32 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
8.6%
38/442 • Number of events 47 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
6.8%
30/440 • Number of events 39 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Infections and infestations
Urinary tract infection
|
5.3%
23/432 • Number of events 27 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
7.7%
34/442 • Number of events 40 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
4.3%
19/440 • Number of events 26 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
2.1%
1/48 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.9%
30/432 • Number of events 37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
5.0%
22/442 • Number of events 26 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
4.8%
21/440 • Number of events 25 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.8%
25/432 • Number of events 33 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
6.8%
30/442 • Number of events 34 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
3.6%
16/440 • Number of events 17 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Nervous system disorders
Ageusia
|
1.4%
6/432 • Number of events 6 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
2.9%
13/442 • Number of events 14 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
15.2%
67/440 • Number of events 75 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Nervous system disorders
Dysgeusia
|
6.5%
28/432 • Number of events 30 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
12.7%
56/442 • Number of events 64 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
43.9%
193/440 • Number of events 220 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Nervous system disorders
Headache
|
15.5%
67/432 • Number of events 128 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
16.7%
74/442 • Number of events 131 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
15.9%
70/440 • Number of events 131 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
2.1%
1/48 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Nervous system disorders
Hypogeusia
|
0.69%
3/432 • Number of events 3 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
3.8%
17/442 • Number of events 18 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
13.6%
60/440 • Number of events 60 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Nervous system disorders
Taste disorder
|
0.23%
1/432 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
1.8%
8/442 • Number of events 8 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
8.4%
37/440 • Number of events 39 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.5%
11/432 • Number of events 13 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
2.9%
13/442 • Number of events 18 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
4.3%
19/440 • Number of events 29 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
2.1%
1/48 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
8.1%
3/37 • Number of events 3 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
2.7%
1/37 • Number of events 1 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
18/432 • Number of events 20 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
6.8%
30/442 • Number of events 37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
7.0%
31/440 • Number of events 38 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.4%
19/432 • Number of events 21 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
2.9%
13/442 • Number of events 13 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
5.2%
23/440 • Number of events 24 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/48 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
0.00%
0/37 • On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 18006726372
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. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER