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| ID | Type | Description | Link |
|---|---|---|---|
| MK-7264-043 | Other Identifier | Merck Protocol Number | |
| 2019-002308-42 | EudraCT Number |
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The purpose of this study is to evaluate the efficacy and safety of gefapixant in participants with recent onset chronic cough (duration >8 weeks after onset of cough symptoms) for <12 months and a diagnosis of refractory or unexplained chronic cough. The primary hypothesis is that gefapixant is superior to placebo in improving cough-related quality of life measured as change from baseline in the Leicester Cough Questionnaire (LCQ) total score at Week 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gefapixant | Experimental | Participants will receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks. |
|
| Placebo | Placebo Comparator | Participants will receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gefapixant | Drug | Administered twice daily as an oral tablet of 45 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12 | Participants will be asked to complete the LCQ to assess the impact of their cough severity on health related quality of life (HRQoL) over the past 2 weeks. The LCQ is a 19-item, cough-specific HRQoL questionnaire. Each item on the LCQ assesses symptoms using a 7-point scale ranging from 1 to 7. The LCQ contains three domains on physical, psychological, and social functioning, and each domain score is calculated as the mean score of the items (range: 1 to 7) within the domain. The LCQ total score is the sum of the 3 domains, with a range from 3 (lowest total score) to 21 (highest total score). Higher scores indicate better HRQoL. The change from baseline in LCQ total score is calculated. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score at Week 12 | Participants will be asked to complete the VAS questionnaire to assess the severity of their cough over the past 24-hours. The Cough Severity VAS is a single-item questionnaire asking the participant to rate the severity of their cough on a 100-point scale ranging from 0 ("No Cough") to 100 ("Extremely Severe Cough"). Higher scores indicate greater severity of cough. The change from baseline in VAS score is calculated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Associates, PA ( Site 0016) | Phoenix | Arizona | 85032 | United States | ||
| Center for Clinical Trials, LLC ( Site 0035) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36879087 | Result | McGarvey L, Sher M, Shvarts YG, Lu S, Wu WC, Xu P, Schelfhout J, La Rosa C, Nguyen AM, Reyfman PA, Afzal AS. The Efficacy and Safety of Gefapixant in a Phase 3b Trial of Patients with Recent-Onset Chronic Cough. Lung. 2023 Apr;201(2):111-118. doi: 10.1007/s00408-023-00606-w. Epub 2023 Mar 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gefapixant | Participants receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks. |
| FG001 | Placebo | Participants receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 25, 2020 |
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| Placebo | Drug | Administered twice daily as a placebo oral tablet matching gefapixant |
|
| Baseline, Week 12 |
| Percentage of Participants With One or More Adverse Events (AEs) | An AE is defined as 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. The percentage of participants with one or more AEs is presented. | Up to approximately 14 weeks |
| Percentage of Participants Who Discontinue Study Drug Due to an AE | An AE is defined as 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. The percentage of participants who discontinue study drug due to an AE is presented. | Up to approximately 12 weeks |
| Paramount |
| California |
| 90723 |
| United States |
| Springfield Clinic, LLP ( Site 0018) | Springfield | Illinois | 62703 | United States |
| Chesapeake Clinical Research, Inc ( Site 0037) | White Marsh | Maryland | 21162 | United States |
| Albuquerque Clinical Trials ( Site 0030) | Albuquerque | New Mexico | 87102 | United States |
| Montefiore Einstein Center ( Site 0022) | The Bronx | New York | 10461 | United States |
| American Health Research ( Site 0047) | Charlotte | North Carolina | 28277 | United States |
| Clinical Research Institute of Southern Oregon, PC ( Site 0028) | Medford | Oregon | 97504 | United States |
| Northwest Research Center ( Site 0039) | Portland | Oregon | 97202 | United States |
| AAPRI Clinical Research Institute ( Site 0051) | Lincoln | Rhode Island | 02865 | United States |
| Allergic Disease and Asthma Center ( Site 0027) | Greenville | South Carolina | 29607 | United States |
| Diagnostics Research Group ( Site 0021) | San Antonio | Texas | 78229 | United States |
| Allergy & Asthma Center ( Site 0001) | Waco | Texas | 76712 | United States |
| Tidewater Physician Multispecialty Group, PC ( Site 0048) | Williamsburg | Virginia | 23188 | United States |
| Bellingham Asthma & Allergy ( Site 0011) | Bellingham | Washington | 98225 | United States |
| Recherche GCP Research ( Site 0802) | Montreal | Quebec | H1M 1B1 | Canada |
| Diex Recherche Quebec Inc ( Site 0805) | Québec | Quebec | G1N 4V3 | Canada |
| Clinique Specialisee en Allergie de la Capitale - CSAC ( Site 0800) | Québec | Quebec | G1V 4W2 | Canada |
| Fundacion Centro de Investigacion Clinica CIC ( Site 0401) | Medellín | Antioquia | 050021 | Colombia |
| Universidad Pontificia Bolivariana - Clinica Universitaria Bolivariana ( Site 0408) | Medellín | Antioquia | 050036 | Colombia |
| MedPlus Medicina Prepagada S.A. ( Site 0402) | Bogotá | Bogota D.C. | 110221 | Colombia |
| Centro Especializado en Enfermedades Pulmonares. ( Site 0410) | Bogotá | Bogota D.C. | 111831 | Colombia |
| Healthy Medical Center S.A.S ( Site 0404) | Zipaquirá | Cundinamarca | 250252 | Colombia |
| Instituto Neumologico del Oriente ( Site 0403) | Floridablanca | Santander Department | 681004 | Colombia |
| Zentrum fuer ambulante pneumologische Forschung Marburg GbR ( Site 0910) | Marburg | Hesse | 35037 | Germany |
| Ballenberger Freytag Wenisch Institut fuer klinische Forschung GmbH ( Site 0917) | Neu-Isenburg | Hesse | 63263 | Germany |
| Pneumologicum im Suedstadtforum ( Site 0916) | Hanover | Lower Saxony | 30173 | Germany |
| Pneumologisches Studienzentrum ( Site 0911) | Berlin | 10969 | Germany |
| Celan SA ( Site 0500) | Guatemala City | 01010 | Guatemala |
| Clinica Medica Especializada en Neumologia y Tisiologia ( Site 0504) | Guatemala City | 01010 | Guatemala |
| Clinica Medica Especializada en Neumologia ( Site 0502) | Guatemala City | 01011 | Guatemala |
| Private Clinic ( Site 0505) | Guatemala City | 01011 | Guatemala |
| Clinica Privada Dr. Jose Francisco Flores Lopez ( Site 0503) | Guatemala City | 01015 | Guatemala |
| Instituto De Alergias y Enfermedades Respiratorias ( Site 0501) | Guatemala City | 01015 | Guatemala |
| Clinica Ricardo Palma ( Site 0601) | San Isidro | Lima region | 15036 | Peru |
| Asociacion Civil por la Salud ( Site 0602) | Lima | 15046 | Peru |
| Hospital Nacional Arzobispo Loayza ( Site 0607) | Lima | 15082 | Peru |
| Clinica Belen ( Site 0604) | Piura | 20001 | Peru |
| Centrum Medyczne Pratia Bydgoszcz ( Site 1206) | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-796 | Poland |
| Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 1203) | Krakow | Lesser Poland Voivodeship | 30-033 | Poland |
| NZOZ CENTRUM ALERGOLOGII ( Site 1207) | Lublin | Lublin Voivodeship | 20-552 | Poland |
| RCMed ( Site 1202) | Sochaczew | Masovian Voivodeship | 96-500 | Poland |
| Centrum Medyczne Puławska ( Site 1215) | Warsaw | Masovian Voivodeship | 02-777 | Poland |
| Centrum Medyczne Lucyna Andrzej Dymek - Zawadzkie ( Site 1200) | Zawadzkie | Opole Voivodeship | 47-120 | Poland |
| Centrum Medyczne Pratia Katowice ( Site 1205) | Katowice | Silesian Voivodeship | 40-081 | Poland |
| Centrum Medyczne Silmedic Sp z o o ( Site 1204) | Katowice | Silesian Voivodeship | 40-282 | Poland |
| Gyncentrum Clinic Sp. z o.o. ( Site 1208) | Katowice | Silesian Voivodeship | 40-851 | Poland |
| RSBHI Belgorod regional clinical hospital of Prelate Ioasafa ( Site 1417) | Belgorod | Belgorod Oblast | 308007 | Russia |
| GBUZ Regional Clinical Hospital 3 ( Site 1421) | Chelyabinsk | Chelyabinsk Oblast | 454021 | Russia |
| City Clinical Hospital No. 3 them. M. A. Podgorbunskogo ( Site 1401) | Kemerovo | Kemerovo Oblast | 650000 | Russia |
| Moscow City Clinical Hospital Number 13 ( Site 1460) | Moscow | Moscow | 115280 | Russia |
| Open Joint Stock Company Clinical and Diagnostic Center Euromedservice ( Site 1467) | Moscow | Moscow | 115419 | Russia |
| Clinic of FSBEI HE OmSMU of Minzdrav ( Site 1439) | Omsk | Omsk Oblast | 644050 | Russia |
| SPb SBHI City Consultative Diagnostic Center 1 ( Site 1409) | Saint Petersburg | Sankt-Peterburg | 194354 | Russia |
| GBUZ LO Center of Occupational Pathology ( Site 1447) | Saint Petersburg | Sankt-Peterburg | 195271 | Russia |
| Limited Liability Company Kurator ( Site 1425) | Saint Petersburg | Sankt-Peterburg | 196240 | Russia |
| SEIHPE Saint Petersburg SMU ( Site 1435) | Saint Petersburg | Sankt-Peterburg | 197022 | Russia |
| advisory diagnostic center No.85 ( Site 1455) | Saint Petersburg | Sankt-Peterburg | 198260 | Russia |
| Saratov City Clinical Hospital 2 n.a. V.I. Razumovsky ( Site 1453) | Saratov | Saratov Oblast | 410012 | Russia |
| Family Clinic ( Site 1465) | Yekaterinburg | Sverdlovsk Oblast | 620109 | Russia |
| State health Agency Ulyanovsk regional clinical hospital ( Site 1415) | Ulyanovsk | Ulyanovsk Oblast | 432063 | Russia |
| Voronezh Regional Clinical Hospital #1 ( Site 1441) | Voronezh | Voronezskaja Oblast | 394066 | Russia |
| SBCIH of the Yaroslavl region Central city hospital ( Site 1429) | Yaroslavl | Yaroslavl Oblast | 150040 | Russia |
| Wonju Severance Christian Hospital ( Site 1502) | Wŏnju | Kang-won-do | 26426 | South Korea |
| Asan Medical Center ( Site 1505) | Songpagu | Seoul | 05505 | South Korea |
| Seoul National University Hospital ( Site 1501) | Seoul | 03080 | South Korea |
| Severance Hospital Yonsei University Health System ( Site 1503) | Seoul | 03722 | South Korea |
| Konkuk University Medical Center ( Site 1504) | Seoul | 05030 | South Korea |
| Hospital Parc Tauli ( Site 1821) | Sabadell | Barcelona | 08208 | Spain |
| Hospital Clinico Universitario de Santiago ( Site 1820) | Santiago de Compostela | La Coruna | 15706 | Spain |
| Hospital General Universitario Gregorio Maranon ( Site 1823) | Madrid | Madrid, Comunidad de | 28007 | Spain |
| Hospital Ramon y Cajal ( Site 1815) | Madrid | 28034 | Spain |
| Hospital Clinico San Carlos ( Site 1822) | Madrid | 28040 | Spain |
| Kherson City Clinical Hospital n.a. Y.Y. Karabelesh ( Site 2811) | Kherson | Kherson Oblast | 73000 | Ukraine |
| F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2802) | Kyiv | Kyivska Oblast | 03038 | Ukraine |
| F.G.Yanovskyy Institute of Phthisiology and Pulmonology ( Site 2808) | Kyiv | Kyivska Oblast | 03038 | Ukraine |
| SE Road Clinical Hospital 2 of Kyiv station ( Site 2812) | Kyiv | Kyivska Oblast | 03049 | Ukraine |
| SE O.S.Kolomiychenko Institute of Otolaryngology of NAMS of Ukraine ( Site 2817) | Kyiv | Kyivska Oblast | 03057 | Ukraine |
| Odesa regional clinical hospital ( Site 2804) | Odesa | Odesa Oblast | 65025 | Ukraine |
| City Polyclinic N20 ( Site 2806) | Odesa | Odesa Oblast | 65114 | Ukraine |
| Poltava City Clinical Hospital -1 ( Site 2813) | Poltava | Poltava Oblast | 36039 | Ukraine |
| Private Small-Scale Enterprise Medical Centre "Pulse" ( Site 2809) | Vinnytsia | Vinnytsia Oblast | 21001 | Ukraine |
| Vinnytsia Regional Clinical Hospital n.a. M.I. Pyrogov ( Site 2814) | Vinnytsia | Vinnytsia Oblast | 21018 | Ukraine |
| Volyn Regional Clinical Hospital ( Site 2816) | Lutsk | Volyn Oblast | 43005 | Ukraine |
| MI Zaporizhzhia City Multispecialty Clinical Hospital 9 ( Site 2803) | Zaporizhzhia | Zaporizhzhia Oblast | 69096 | Ukraine |
| Zhytomyr Central City Hospital No. 1 ( Site 2807) | Zhytomyr | Zhytomyr Oblast | 10002 | Ukraine |
| Medical Center of LLC Medical Clinic Blahomed ( Site 2815) | Kyiv | 01023 | Ukraine |
| MeDiNova Yorkshire Dedicated Research Centre ( Site 2715) | Shipley | Bradford | BD18 3SA | United Kingdom |
| West Walk Surgery ( Site 2700) | Yate | Gloucestershire | BS37 4AX | United Kingdom |
| Medinova South London Research Centre ( Site 2706) | Orpington | Kent | BR5 3QG | United Kingdom |
| Medinova North London Dedicated Research Centre ( Site 2705) | Northwood | HA6 2RN | United Kingdom |
| Treated |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gefapixant | Participants receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks. |
| BG001 | Placebo | Participants receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Baseline Leicester Cough Questionnaire (LCQ) | The LCQ is a 19-item, cough-specific health related qualify of life (HRQoL) questionnaire. Each item on the LCQ assesses symptoms using a 7-point scale ranging from 1 to 7. The LCQ contains three domains on physical, psychological, and social functioning, and each domain score is calculated as the mean score of the items (range: 1 to 7) within the domain. The LCQ total score is the sum of the 3 domains, with a range from 3 (lowest total score) to 21 (highest total score). Higher scores indicate better HRQoL | Includes randomized participants who had LCQ total score values at baseline | Mean | Standard Deviation | Scores on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12 | Participants will be asked to complete the LCQ to assess the impact of their cough severity on health related quality of life (HRQoL) over the past 2 weeks. The LCQ is a 19-item, cough-specific HRQoL questionnaire. Each item on the LCQ assesses symptoms using a 7-point scale ranging from 1 to 7. The LCQ contains three domains on physical, psychological, and social functioning, and each domain score is calculated as the mean score of the items (range: 1 to 7) within the domain. The LCQ total score is the sum of the 3 domains, with a range from 3 (lowest total score) to 21 (highest total score). Higher scores indicate better HRQoL. The change from baseline in LCQ total score is calculated. | All randomized participants who have taken at least one dose of study intervention, and had LCQ total score values at both baseline and week 12. Participants were analyzed in the group as randomized. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a Scale | Baseline, Week 12 |
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| Secondary | Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score at Week 12 | Participants will be asked to complete the VAS questionnaire to assess the severity of their cough over the past 24-hours. The Cough Severity VAS is a single-item questionnaire asking the participant to rate the severity of their cough on a 100-point scale ranging from 0 ("No Cough") to 100 ("Extremely Severe Cough"). Higher scores indicate greater severity of cough. The change from baseline in VAS score is calculated. | All randomized participants who have taken at least one dose of study intervention, and had VAS total score values at both baseline and week 12. Participants were analyzed in the group as randomized. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a Scale | Baseline, Week 12 |
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| Secondary | Percentage of Participants With One or More Adverse Events (AEs) | An AE is defined as 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. The percentage of participants with one or more AEs is presented. | All randomized participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated. | Posted | Number | Percentage of Participants | Up to approximately 14 weeks |
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| Secondary | Percentage of Participants Who Discontinue Study Drug Due to an AE | An AE is defined as 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. The percentage of participants who discontinue study drug due to an AE is presented. | All randomized participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated. | Posted | Number | Percentage of Participants | Up to approximately 12 weeks |
|
|
Up to 114 days
All-cause mortality population includes all randomized participants. Serious and other adverse events population includes all participants who received at least 1 dose of study intervention. Participants were analyzed in the group as treated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gefapixant | Participants receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks. | 0 | 208 | 3 | 206 | 105 | 206 |
| EG001 | Placebo | Participants receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks. | 1 | 211 | 4 | 209 | 22 | 209 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial ischaemia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| COVID-19 pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
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| Tonsillar cyst | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ageusia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Hypogeusia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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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. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Sep 19, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000096822 | Chronic Cough |
| D003371 | Cough |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000597312 | Gefapixant |
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