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A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03449147
Recruitment Status : Completed
First Posted : February 28, 2018
Results First Posted : September 2, 2021
Last Update Posted : September 2, 2021
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Cough
Interventions Drug: Placebo
Drug: Gefapixant 15 mg BID
Drug: Gefapixant 45 mg BID
Enrollment 1317
Recruitment Details  
Pre-assignment Details 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).
Arm/Group Title Placebo Gefapixant 15 mg BID Gefapixant 45 mg BID
Hide Arm/Group Description Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period. 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. 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.
Period Title: 52-week Treatment Period
Started 436 442 439
Completed 382 368 355
Not Completed 54 74 84
Reason Not Completed
Death             0             1             0
Lost to Follow-up             6             2             5
Other             0             1             2
Physician Decision             1             0             3
Screen Failure             1             2             0
Withdrawal by Subject             46             68             74
Period Title: 12-Week Off-Treatment Durability Period
Started 48 [1] 37 [1] 37 [1]
Completed 47 36 37
Not Completed 1 1 0
Reason Not Completed
Withdrawal by Subject             1             0             0
Other             0             1             0
[1]
Not all participants continued in the optional Off-Treatment Period.
Arm/Group Title Placebo Gefapixant 15 mg BID Gefapixant 45 mg BID Total
Hide Arm/Group Description Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period. 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. 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 of all reporting groups
Overall Number of Baseline Participants 436 442 439 1317
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 436 participants 442 participants 439 participants 1317 participants
58.4  (12.5) 58.4  (11.3) 57.8  (12.4) 58.2  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 436 participants 442 participants 439 participants 1317 participants
Female
326
  74.8%
331
  74.9%
329
  74.9%
986
  74.9%
Male
110
  25.2%
111
  25.1%
110
  25.1%
331
  25.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 436 participants 442 participants 439 participants 1317 participants
Hispanic or Latino
85
  19.5%
93
  21.0%
89
  20.3%
267
  20.3%
Not Hispanic or Latino
348
  79.8%
347
  78.5%
344
  78.4%
1039
  78.9%
Unknown or Not Reported
3
   0.7%
2
   0.5%
6
   1.4%
11
   0.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 436 participants 442 participants 439 participants 1317 participants
American Indian or Alaska Native
20
   4.6%
28
   6.3%
24
   5.5%
72
   5.5%
Asian
15
   3.4%
14
   3.2%
15
   3.4%
44
   3.3%
Native Hawaiian or Other Pacific Islander
4
   0.9%
2
   0.5%
3
   0.7%
9
   0.7%
Black or African American
5
   1.1%
9
   2.0%
14
   3.2%
28
   2.1%
White
356
  81.7%
358
  81.0%
346
  78.8%
1060
  80.5%
More than one race
36
   8.3%
31
   7.0%
37
   8.4%
104
   7.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Baseline 24-Hour Coughs Per Hour   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Coughs/Hour
Number Analyzed 432 participants 431 participants 434 participants 1297 participants
27.45  (24.44) 26.82  (21.25) 26.84  (27.04) 27.04  (24.35)
[1]
Measure Description: 24-hour coughs per hour is defined as the average hourly cough frequency based on 24-hour sound recordings using a digital recording device (cough monitor).
[2]
Measure Analysis Population Description: All participants with 24-hour coughs per hour data available at baseline
1.Primary Outcome
Title Model-Based Geometric Mean Ratio (GMR) of 24-Hour Coughs Per Hour at Week 24/Baseline
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Gefapixant 15 mg BID Gefapixant 45 mg BID
Hide Arm/Group Description:
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period.
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.
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.
Overall Number of Participants Analyzed 419 415 409
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
0.43
(0.39 to 0.48)
0.43
(0.38 to 0.47)
0.37
(0.33 to 0.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Gefapixant 15 mg BID
Comments Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e**DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.875
Comments Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated Relative Reduction (%)
Estimated Value -1.14
Confidence Interval (2-Sided) 95%
-14.27 to 14.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Gefapixant 45 mg BID
Comments ERR relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e**DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated Relative Reduction (%)
Estimated Value -14.64
Confidence Interval (2-Sided) 95%
-26.07 to -1.43
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants Who Experienced At Least One Adverse Event (AE) During Treatment and Follow-up
Hide Description 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.
Time Frame Up to 54 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Gefapixant 15 mg BID Gefapixant 45 mg BID
Hide Arm/Group Description:
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period.
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.
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.
Overall Number of Participants Analyzed 432 442 440
Measure Type: Count of Participants
Unit of Measure: Participants
349
  80.8%
373
  84.4%
399
  90.7%
3.Primary Outcome
Title Number of Participants Who Discontinued a Study Drug Due to an AE
Hide Description 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.
Time Frame Up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Gefapixant 15 mg BID Gefapixant 45 mg BID
Hide Arm/Group Description:
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period.
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.
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.
Overall Number of Participants Analyzed 432 442 440
Measure Type: Count of Participants
Unit of Measure: Participants
25
   5.8%
40
   9.0%
100
  22.7%
4.Secondary Outcome
Title Model-Based GMR of Awake Coughs Per Hour at Week 24/Baseline
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Gefapixant 15 mg BID Gefapixant 45 mg BID
Hide Arm/Group Description:
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period.
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.
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.
Overall Number of Participants Analyzed 419 415 409
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
0.42
(0.38 to 0.47)
0.41
(0.37 to 0.46)
0.36
(0.32 to 0.40)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Gefapixant 15 mg BID
Comments Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e**DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.677
Comments Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated Relative Reduction (%)
Estimated Value -3.03
Confidence Interval (2-Sided) 95%
-16.14 to 12.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Gefapixant 45 mg BID
Comments ERR relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e**DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated Relative Reduction (%)
Estimated Value -15.79
Confidence Interval (2-Sided) 95%
-27.27 to -2.50
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With a ≥1.3 Point Change From Baseline in the Leicester Questionnaire (LCQ) Total Score at Week 24
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Gefapixant 15 mg BID Gefapixant 45 mg
Hide Arm/Group Description:
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period.
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.
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.
Overall Number of Participants Analyzed 406 404 399
Measure Type: Number
Unit of Measure: Percentage of Participants
70.1 75.9 76.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Gefapixant 15 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.077
Comments Comparison based on logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline LCQ total score, and the interaction of baseline LCQ total score by visit as covariates.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.34
Confidence Interval (2-Sided) 95%
0.97 to 1.85
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Gefapixant 45 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.040
Comments Comparison based on logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline LCQ total score, and the interaction of baseline LCQ total score by visit as covariates.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.41
Confidence Interval (2-Sided) 95%
1.02 to 1.96
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With a ≤-30% Change From Baseline in 24-hour Coughs Per Hour at Week 24
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Gefapixant 15 mg BID Gefapixant 45 mg BID
Hide Arm/Group Description:
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period.
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.
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.
Overall Number of Participants Analyzed 419 415 409
Measure Type: Number
Unit of Measure: Percentage of Participants
66.9 67.4 72.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Gefapixant 15 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.872
Comments Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline 24-hour coughs per hour and the interaction of baseline 24-hour coughs per hour as covariates.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.75 to 1.40
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Gefapixant 45 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.082
Comments Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline 24-hour coughs per hour and the interaction of baseline 24-hour coughs per hour as covariates.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.33
Confidence Interval (2-Sided) 95%
0.96 to 1.83
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With ≤-1.3 Point Change From Baseline of Mean Weekly Cough Severity Diary (CSD) Total Score at Week 24
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Gefapixant 15 mg BID Gefapixant 45 mg
Hide Arm/Group Description:
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period.
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.
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.
Overall Number of Participants Analyzed 428 426 425
Measure Type: Number
Unit of Measure: Percentage of Participants
69.1 74.8 77.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Gefapixant 15 mg BID
Comments Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.33
Confidence Interval (2-Sided) 95%
0.96 to 1.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Gefapixant 45 mg
Comments Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.50
Confidence Interval (2-Sided) 95%
1.08 to 2.09
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants With ≤-2.7 Point Change From Baseline of Mean Weekly CSD Total Score at Week 24
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Gefapixant 15 mg BID Gefapixant 45 mg
Hide Arm/Group Description:
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period.
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.
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.
Overall Number of Participants Analyzed 428 426 425
Measure Type: Number
Unit of Measure: Percentage of Participants
41.0 46.6 55.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Gefapixant 15 mg BID
Comments Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.25
Confidence Interval (2-Sided) 95%
0.93 to 1.69
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Gefapixant 45 mg
Comments Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.77
Confidence Interval (2-Sided) 95%
1.31 to 2.39
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants With a ≤-30 Millimeter (mm) Change From Baseline in Cough Severity Visual Analog Scale (VAS) Score at Week 24
Hide Description 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.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Gefapixant 15 mg BID Gefapixant 45 mg
Hide Arm/Group Description:
Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period.
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.
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.
Overall Number of Participants Analyzed 428 426 425
Measure Type: Number
Unit of Measure: Percentage of participants
40.9 51.4 53.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Gefapixant 15 mg BID
Comments Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly VAS score, and the interaction of baseline mean weekly VAS score by visit as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.53
Confidence Interval (2-Sided) 95%
1.14 to 2.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Gefapixant 45 mg
Comments Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly VAS score, and the interaction of baseline mean weekly VAS score by visit as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.65
Confidence Interval 95%
1.23 to 2.22
Estimation Comments [Not Specified]
Time Frame On-Treatment Period: Up to Week 54; Off-Treatment (Off-Tx) Period: From Week 52 through Week 64 (approximately 12 weeks)
Adverse Event Reporting Description All-cause mortality (ACM) includes all randomized participants; serious and other AEs include all randomized participants who took ≥1 one dose of study drug. In the treatment period, 3 participants randomized to placebo who took ≥1 incorrect dose(s) of study drug were counted as follows: 2 participants were analyzed in the gefapixant 15 mg arm and 1 in the gefapixant 45 mg arm. AEs and ACM were reported separately for the Treatment Period (MedDRA 23.0) and Off-Tx Period (MedDRA 23.1).
 
Arm/Group Title Placebo Gefapixant 15 mg BID Gefapixant 45 mg BID Placebo: Off Tx Gefapixant 15 mg BID: Off Tx Gefapixant 45 mg BID: Off Tx
Hide Arm/Group Description Participants received dose-matched placebo tablets twice daily (BID) during the 24-week main study period and 28-week extension period. 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. 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. 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). 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). 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).
All-Cause Mortality
Placebo Gefapixant 15 mg BID Gefapixant 45 mg BID Placebo: Off Tx Gefapixant 15 mg BID: Off Tx Gefapixant 45 mg BID: Off Tx
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/433 (0.00%)      1/444 (0.23%)      0/440 (0.00%)      0/48 (0.00%)      0/37 (0.00%)      0/37 (0.00%)    
Hide Serious Adverse Events
Placebo Gefapixant 15 mg BID Gefapixant 45 mg BID Placebo: Off Tx Gefapixant 15 mg BID: Off Tx Gefapixant 45 mg BID: Off Tx
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/432 (5.79%)      24/442 (5.43%)      25/440 (5.68%)      0/48 (0.00%)      0/37 (0.00%)      1/37 (2.70%)    
Blood and lymphatic system disorders             
Leukopenia  1  0/432 (0.00%)  0 0/442 (0.00%)  0 1/440 (0.23%)  1 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Cardiac disorders             
Arrhythmia  1  0/432 (0.00%)  0 0/442 (0.00%)  0 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 1/37 (2.70%)  1
Atrial fibrillation  1  0/432 (0.00%)  0 0/442 (0.00%)  0 1/440 (0.23%)  1 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Cardiopulmonary failure  1  0/432 (0.00%)  0 1/442 (0.23%)  1 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Myocardial infarction  1  1/432 (0.23%)  1 0/442 (0.00%)  0 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Myocardial ischaemia  1  0/432 (0.00%)  0 0/442 (0.00%)  0 1/440 (0.23%)  1 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Congenital, familial and genetic disorders             
Congenital choroid plexus cyst  1  0/432 (0.00%)  0 1/442 (0.23%)  1 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Eye disorders             
Cataract  1  0/432 (0.00%)  0 0/442 (0.00%)  0 1/440 (0.23%)  1 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Gastrointestinal disorders             
Constipation  1  0/432 (0.00%)  0 1/442 (0.23%)  1 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Gastritis  1  2/432 (0.46%)  2 0/442 (0.00%)  0 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Small intestinal obstruction  1  0/432 (0.00%)  0 0/442 (0.00%)  0 1/440 (0.23%)  1 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Umbilical hernia  1  0/432 (0.00%)  0 1/442 (0.23%)  1 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
General disorders             
Pyrexia  1  1/432 (0.23%)  1 0/442 (0.00%)  0 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Hepatobiliary disorders             
Bile duct stone  1  0/432 (0.00%)  0 1/442 (0.23%)  1 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Infections and infestations             
Bronchitis  1  1/432 (0.23%)  1 0/442 (0.00%)  0 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
COVID-19 pneumonia  1  1/432 (0.23%)  1 0/442 (0.00%)  0 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Chronic tonsillitis  1  0/432 (0.00%)  0 1/442 (0.23%)  1 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Diverticulitis  1  1/432 (0.23%)  1 0/442 (0.00%)  0 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Gastroenteritis  1  1/432 (0.23%)  1 0/442 (0.00%)  0 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Influenza  1  0/432 (0.00%)  0 2/442 (0.45%)  2 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Lung abscess  1  1/432 (0.23%)  1 0/442 (0.00%)  0 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Osteomyelitis  1  0/432 (0.00%)  0 0/442 (0.00%)  0 1/440 (0.23%)  1 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Pneumonia  1  0/432 (0.00%)  0 3/442 (0.68%)  3 1/440 (0.23%)  1 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Pneumonia bacterial  1  0/432 (0.00%)  0 1/442 (0.23%)  1 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Respiratory tract infection  1  1/432 (0.23%)  1 0/442 (0.00%)  0 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Tonsillitis bacterial  1  0/432 (0.00%)  0 0/442 (0.00%)  0 1/440 (0.23%)  1 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Upper respiratory tract infection  1  1/432 (0.23%)  1 0/442 (0.00%)  0 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Urinary tract infection enterococcal  1  0/432 (0.00%)  0 0/442 (0.00%)  0 1/440 (0.23%)  1 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Urosepsis  1  2/432 (0.46%)  2 0/442 (0.00%)  0 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Vulval abscess  1  0/432 (0.00%)  0 0/442 (0.00%)  0 1/440 (0.23%)  1 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Injury, poisoning and procedural complications             
Ankle fracture  1  0/432 (0.00%)  0 1/442 (0.23%)  1 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Cervical vertebral fracture  1  1/432 (0.23%)  1 0/442 (0.00%)  0 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Concussion  1  0/432 (0.00%)  0 0/442 (0.00%)  0 1/440 (0.23%)  1 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Disinfectant poisoning  1  0/432 (0.00%)  0 0/442 (0.00%)  0 1/440 (0.23%)  1 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Ligament injury  1  0/432 (0.00%)  0 1/442 (0.23%)  1 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Procedural pain  1  0/432 (0.00%)  0 0/442 (0.00%)  0 1/440 (0.23%)  1 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Rib fracture  1  1/432 (0.23%)  1 0/442 (0.00%)  0 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Sternal fracture  1  1/432 (0.23%)  1 0/442 (0.00%)  0 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Stress fracture  1  0/432 (0.00%)  0 0/442 (0.00%)  0 1/440 (0.23%)  1 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Upper limb fracture  1  0/432 (0.00%)  0 0/442 (0.00%)  0 1/440 (0.23%)  1 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Wrist fracture  1  1/432 (0.23%)  1 0/442 (0.00%)  0 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Metabolism and nutrition disorders             
Hypoglycaemia  1  0/432 (0.00%)  0 0/442 (0.00%)  0 1/440 (0.23%)  1 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Back pain  1  0/432 (0.00%)  0 0/442 (0.00%)  0 1/440 (0.23%)  1 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Groin pain  1  0/432 (0.00%)  0 1/442 (0.23%)  1 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Intervertebral disc protrusion  1  0/432 (0.00%)  0 1/442 (0.23%)  1 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Muscle twitching  1  0/432 (0.00%)  0 1/442 (0.23%)  1 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Osteoarthritis  1  1/432 (0.23%)  1 0/442 (0.00%)  0 1/440 (0.23%)  1 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Rotator cuff syndrome  1  0/432 (0.00%)  0 0/442 (0.00%)  0 1/440 (0.23%)  1 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Spinal stenosis  1  1/432 (0.23%)  1 1/442 (0.23%)  1 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Spondylolisthesis  1  0/432 (0.00%)  0 0/442 (0.00%)  0 1/440 (0.23%)  1 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Basal cell carcinoma  1  0/432 (0.00%)  0 1/442 (0.23%)  1 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Colon cancer metastatic  1  0/432 (0.00%)  0 1/442 (0.23%)  1 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Salivary gland neoplasm  1  1/432 (0.23%)  1 0/442 (0.00%)  0 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Spinal meningioma benign  1  0/432 (0.00%)  0 0/442 (0.00%)  0 1/440 (0.23%)  1 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Uterine leiomyoma  1  0/432 (0.00%)  0 1/442 (0.23%)  1 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Nervous system disorders             
Cerebrospinal fluid leakage  1  0/432 (0.00%)  0 1/442 (0.23%)  1 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Cerebrovascular accident  1  0/432 (0.00%)  0 1/442 (0.23%)  1 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Hypertensive encephalopathy  1  1/432 (0.23%)  1 0/442 (0.00%)  0 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Migraine  1  0/432 (0.00%)  0 1/442 (0.23%)  1 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Myasthenia gravis  1  0/432 (0.00%)  0 0/442 (0.00%)  0 1/440 (0.23%)  1 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Syncope  1  1/432 (0.23%)  1 0/442 (0.00%)  0 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Transient ischaemic attack  1  0/432 (0.00%)  0 1/442 (0.23%)  1 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Psychiatric disorders             
Confusional state  1  1/432 (0.23%)  1 0/442 (0.00%)  0 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Stress  1  0/432 (0.00%)  0 1/442 (0.23%)  1 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Suicide attempt  1  1/432 (0.23%)  1 0/442 (0.00%)  0 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Renal and urinary disorders             
Nephrolithiasis  1  0/432 (0.00%)  0 0/442 (0.00%)  0 1/440 (0.23%)  1 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Urinary retention  1  0/432 (0.00%)  0 1/442 (0.23%)  1 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Asthma  1  1/432 (0.23%)  1 1/442 (0.23%)  1 1/440 (0.23%)  1 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Bronchial hyperreactivity  1  1/432 (0.23%)  1 0/442 (0.00%)  0 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Cough  1  0/432 (0.00%)  0 0/442 (0.00%)  0 1/440 (0.23%)  1 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Idiopathic pulmonary fibrosis  1  1/432 (0.23%)  1 0/442 (0.00%)  0 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Laryngeal stenosis  1  2/432 (0.46%)  2 0/442 (0.00%)  0 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Pulmonary embolism  1  0/432 (0.00%)  0 1/442 (0.23%)  1 1/440 (0.23%)  1 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Pulmonary fibrosis  1  1/432 (0.23%)  1 0/442 (0.00%)  0 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Vascular disorders             
Aortic dissection  1  1/432 (0.23%)  1 0/442 (0.00%)  0 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Hypertensive crisis  1  0/432 (0.00%)  0 1/442 (0.23%)  1 0/440 (0.00%)  0 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Orthostatic hypotension  1  0/432 (0.00%)  0 0/442 (0.00%)  0 1/440 (0.23%)  1 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Gefapixant 15 mg BID Gefapixant 45 mg BID Placebo: Off Tx Gefapixant 15 mg BID: Off Tx Gefapixant 45 mg BID: Off Tx
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   248/432 (57.41%)      290/442 (65.61%)      359/440 (81.59%)      6/48 (12.50%)      3/37 (8.11%)      1/37 (2.70%)    
Gastrointestinal disorders             
Diarrhoea  1  18/432 (4.17%)  20 27/442 (6.11%)  29 27/440 (6.14%)  34 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Dry mouth  1  11/432 (2.55%)  12 15/442 (3.39%)  15 32/440 (7.27%)  34 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Nausea  1  32/432 (7.41%)  42 26/442 (5.88%)  33 47/440 (10.68%)  57 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Infections and infestations             
Bronchitis  1  23/432 (5.32%)  27 20/442 (4.52%)  24 18/440 (4.09%)  19 2/48 (4.17%)  2 0/37 (0.00%)  0 0/37 (0.00%)  0
Influenza  1  35/432 (8.10%)  45 29/442 (6.56%)  35 24/440 (5.45%)  27 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Nasopharyngitis  1  70/432 (16.20%)  101 93/442 (21.04%)  128 70/440 (15.91%)  95 2/48 (4.17%)  2 0/37 (0.00%)  0 0/37 (0.00%)  0
Sinusitis  1  18/432 (4.17%)  20 23/442 (5.20%)  25 14/440 (3.18%)  16 1/48 (2.08%)  1 0/37 (0.00%)  0 0/37 (0.00%)  0
Upper respiratory tract infection  1  26/432 (6.02%)  32 38/442 (8.60%)  47 30/440 (6.82%)  39 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Urinary tract infection  1  23/432 (5.32%)  27 34/442 (7.69%)  40 19/440 (4.32%)  26 1/48 (2.08%)  1 0/37 (0.00%)  0 0/37 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Arthralgia  1  30/432 (6.94%)  37 22/442 (4.98%)  26 21/440 (4.77%)  25 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Back pain  1  25/432 (5.79%)  33 30/442 (6.79%)  34 16/440 (3.64%)  17 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Nervous system disorders             
Ageusia  1  6/432 (1.39%)  6 13/442 (2.94%)  14 67/440 (15.23%)  75 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Dysgeusia  1  28/432 (6.48%)  30 56/442 (12.67%)  64 193/440 (43.86%)  220 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Headache  1  67/432 (15.51%)  128 74/442 (16.74%)  131 70/440 (15.91%)  131 1/48 (2.08%)  1 0/37 (0.00%)  0 0/37 (0.00%)  0
Hypogeusia  1  3/432 (0.69%)  3 17/442 (3.85%)  18 60/440 (13.64%)  60 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Taste disorder  1  1/432 (0.23%)  1 8/442 (1.81%)  8 37/440 (8.41%)  39 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Asthma  1  11/432 (2.55%)  13 13/442 (2.94%)  18 19/440 (4.32%)  29 1/48 (2.08%)  1 3/37 (8.11%)  3 1/37 (2.70%)  1
Cough  1  18/432 (4.17%)  20 30/442 (6.79%)  37 31/440 (7.05%)  38 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
Oropharyngeal pain  1  19/432 (4.40%)  21 13/442 (2.94%)  13 23/440 (5.23%)  24 0/48 (0.00%)  0 0/37 (0.00%)  0 0/37 (0.00%)  0
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 18006726372
EMail: ClinicalTrialsDisclosure@merck.com
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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT03449147    
Other Study ID Numbers: 7264-030
MK-7264-030 ( Other Identifier: Merck Protocol Number )
2017-003559-49 ( EudraCT Number )
First Submitted: February 22, 2018
First Posted: February 28, 2018
Results First Submitted: August 9, 2021
Results First Posted: September 2, 2021
Last Update Posted: September 2, 2021