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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-501506-36-00 | Registry Identifier | EU CT | |
| MK-3475A-D77 | Other Identifier | MSD | |
| jRCT2031230049 | Registry Identifier | Japan Registry of Clinical Trials (jRCT) | |
| U1111-1280-9384 | Registry Identifier | UTN |
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This study is to assess the pharmacokinetics (PK) and safety of SC pembrolizumab formulated with berahyaluronidase alfa (MK-3475A) versus (vs) intravenous (IV) pembrolizumab (MK-3475), administered with chemotherapy in first line treatment of adult participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are pembrolizumab formulated with berahyaluronidase alfa subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy | Experimental | Participants with treatment-naïve metastatic NSCLC receive 790 mg of Pembrolizumab Formulated With Berahyaluronidase Alfa via subcutaneous (SC) injection on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy. |
|
| Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy | Active Comparator | Participants with treatment-naïve metastatic NSCLC receive 400 mg pembrolizumab intravenous (IV) infusion in combination with platinum doublet chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab Formulated with Berahyaluronidase Alfa | Biological | Pembrolizumab (+) Berahyaluronidase alfa SC will be administered for squamous and nonsquamous NSCLC as per the schedule specified in arm; participants may be eligible for second course. |
| Measure | Description | Time Frame |
|---|---|---|
| Cycle 1: Area Under the Curve From Time 0 to 6 Weeks (AUC0-6 Weeks) of Pembrolizumab After the First Dose | AUC0-6 weeks was defined as a measure of pembrolizumab exposure that was calculated as the product of serum drug concentration and time from zero to 6 weeks. Blood samples were collected at pre-specified timepoints to determine AUC0-6 weeks. Per protocol, geometric mean AUC0-6 weeks value of pembrolizumab after the first dose of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and after first dose of pembrolizumab in arm 2 was presented. | Cycle 1: Arm 1: Day 1: Predose and Days 2, 3, 4, 5, 6, 7, 10, 15, 29, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4, 15, 29, and 42 postdose (cycle length = 42 days) |
| Cycle 3: Trough Serum Concentration (Ctrough) of Pembrolizumab at Steady State | Ctrough was defined as the lowest serum concentration of pembrolizumab reached at steady state. Blood samples were collected at pre-specified timepoints for the determination of Ctrough. Per protocol, geometric mean Ctrough value of pembrolizumab at steady state of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and of pembrolizumab in arm 2 was presented. | Cycle 3: Arm 1: Day 1: Predose and Days 4, 10, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4 and 42 postdose (cycle length = 42 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Cycle 1: Maximum Serum Concentration (Cmax) of Pembrolizumab After the First Dose | Cmax was defined as the maximum serum concentration of pembrolizumab reached after first dose. Blood samples were collected at pre-specified timepoints for the determination of Cmax. Per protocol, geometric mean Cmax value of pembrolizumab after the first dose of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and after first dose of pembrolizumab in arm 2 was presented. |
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The key inclusion and exclusion criteria include but are not limited to the following:
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 |
|---|---|---|---|---|---|---|
| St. Joseph's Hospital and Medical Center-Dignity Health Cancer Institute ( Site 0023) | Phoenix | Arizona | 85004 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40157574 | Result | Felip E, Rojas CI, Schenker M, Kowalski DM, Casarini IA, Csoszi T, Sendur MAN, Martins J, Calles Blanco A, Wang CC, Wang M, Ramirez Fallas RAL, Yoshioka H, Nair S, Song X, Deng X, Lala M, Eiras R, Takahashi T. Subcutaneous versus intravenous pembrolizumab, in combination with chemotherapy, for treatment of metastatic non-small-cell lung cancer: the phase III 3475A-D77 trial. Ann Oncol. 2025 Jul;36(7):775-785. doi: 10.1016/j.annonc.2025.03.012. Epub 2025 Mar 27. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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All randomized participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy | Participants with treatment-naïve metastatic NSCLC receive 790 mg of Pembrolizumab Formulated With Berahyaluronidase Alfa via subcutaneous (SC) injection on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy. |
| 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 | Feb 6, 2024 |
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| Pemetrexed | Drug | Pemetrexed 500 mg/m² by IV Infusion will be administered for nonsquamous NSCLC as per the schedule specified in arm. |
|
|
| Cisplatin | Drug | Cisplatin 75 mg/m² by IV Infusion will be administered for nonsquamous and squamous NSCLC as per the schedule specified in arm. |
|
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| Carboplatin | Drug | Carboplatin AUC 5 mg/mL/min in nonsquamous and AUC 6 mg/mL/min in squamous NSCLC will be administered as per the schedule specified in arm. |
|
| Paclitaxel | Drug | Paclitaxel 200 mg/m² by IV Infusion will be administered for squamous NSCLC as per the schedule specified in arm. |
|
|
| Nab-paclitaxel | Drug | Nab-paclitaxel 100 mg/m² by IV Infusion will be administered for squamous NSCLC as per the schedule specified in arm. |
|
|
| Pembrolizumab | Biological | Pembrolizumab by IV Infusion will be administered for squamous and nonsquamous NSCLC as per the schedule specified in arm; participants may be eligible for second course. |
|
|
| Filgrastim | Drug | Filgrastim will be administered as per the schedule specified for the arm. |
|
| Pegylated filgrastim | Drug | Pegylated filgrastim will be administered as per the schedule specified for the arm. |
|
| Cycle 1: Arm 1: Day 1: Predose and Days 2, 3, 4, 5, 6, 7, 10, 15, 29, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4, 15, 29, and 42 postdose (cycle length = 42 days) |
| Cycle 1: Trough Serum Concentration (Ctrough) of Pembrolizumab After the First Dose | Ctrough was defined as the lowest serum concentration of pembrolizumab reached after first dose. Blood samples were collected at pre-specified timepoints for the determination of Ctrough. Per protocol, geometric mean Ctrough value of pembrolizumab after the first dose of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and after first dose of pembrolizumab in arm 2 was presented. | Cycle 1: Arm 1: Day 1: Predose and Days 2, 3, 4, 5, 6, 7, 10, 15, 29, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4, 15, 29, and 42 postdose (cycle length = 42 days) |
| Cycle 3: Area Under the Curve From Time 0 to 6 Weeks (AUC0-6 Weeks) of Pembrolizumab at Steady State | AUC0-6 weeks was defined as a measure of pembrolizumab exposure that was calculated as the product of serum drug concentration and time from zero to 6 weeks. Blood samples were collected at pre-specified timepoints to determine AUC0-6 weeks. Per protocol, geometric mean AUC0-6 weeks value of pembrolizumab at steady state of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and pembrolizumab in arm 2 was presented. | Cycle 3: Arm 1: Day 1: Predose and Days 4, 10, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4 and 42 postdose (cycle length = 42 days) |
| Cycle 3: Maximum Serum Concentration (Cmax) of Pembrolizumab at Steady State | Cmax was defined as the maximum serum concentration of pembrolizumab reached at steady state. Blood samples were collected at pre-specified timepoints to determine Cmax. Per protocol, geometric mean Cmax value of pembrolizumab at steady state of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and pembrolizumab in arm 2 was presented. | Cycle 3: Arm 1: Day 1: Predose and Days 4, 10, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4 and 42 postdose (cycle length = 42 days) |
| Number of Participants Who Test Positive for Anti-Drug Antibodies (ADAs) for Pembrolizumab | Blood samples were collected at designated time points for the determination of the presence or absence of anti-pembrolizumab antibodies. Per protocol, the number of participants who developed anti pembrolizumab antibodies were reported. | Predose and Postdose on Day 1 of Cycles 1 through 18 (up to approximately 28 months). Each cycle is 6 weeks. |
| Objective Response Rate (ORR) | ORR was defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experienced CR or PR as assessed by Blinded Independent Central Review (BICR) were presented. | Up to approximately 28 months |
| Progression-free Survival (PFS) | PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR were presented. | Up to approximately 28 months |
| Overall Survival (OS) | OS was defined as the time from randomization to death due to any cause. | Up to approximately 28 months |
| Duration of Response (DOR) | For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR were presented. | Up to approximately 28 months |
| Number of Participants Who Experienced at Least One Adverse Event (AE) | An AE was 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 number of participants who experienced at least one AE were reported . | Up to approximately 28 months |
| Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE) | 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. The number of participants who discontinue study treatment due to an AE will be reported for Arms 1 and 2. | Up to approximately 28 months |
| Change From Baseline in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core30 (QLQ-C30) Combined Global Health Status/Quality of Life (Items 29 & 30) Scale Combined Score | EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. Per protocol, the change from baseline in GHS and QoL combined score was presented. | Baseline and Week 24 |
| Change From Baseline in Physical Functioning (EORTC-QLQ-C30 Items 1-5) Score | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score was presented. | Baseline and Week 24 |
| Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Role Functioning Score-Items 6 and 7 | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and "Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. Higher scores indicate a better level of role functioning. Change from baseline in the EORTC QLQ-C30 role functioning (Items 6-7) combined score was presented. | Baseline and Week 24 |
| Clermont Oncology Center ( Site 0018) |
| Clermont |
| Florida |
| 34711 |
| United States |
| Mid Florida Hematology and Oncology Center ( Site 0010) | Orange City | Florida | 32763 | United States |
| University of Illinois at Chicago-University of Illinois Cancer Center ( Site 0022) | Chicago | Illinois | 60612 | United States |
| Orchard Healthcare Research Inc. ( Site 0011) | Skokie | Illinois | 60077 | United States |
| Franciscan Health Lafayette East ( Site 0020) | Lafayette | Indiana | 47905 | United States |
| Mercy Health-Paducah Cancer Center ( Site 0006) | Paducah | Kentucky | 42003 | United States |
| Hattiesburg Clinic Hematology/Oncology ( Site 0008) | Hattiesburg | Mississippi | 39401 | United States |
| Central Care Cancer Center - Bolivar ( Site 0017) | Bolivar | Missouri | 65613 | United States |
| Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 1005) | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1199ABB | Argentina |
| Instituto de Investigaciones Clínicas Mar del Plata ( Site 1001) | Mar del Plata | Buenos Aires | B7600FZO | Argentina |
| Instituto Argentino de Diagnóstico y Tratamiento (IADT) ( Site 1002) | Buenos Aires | Buenos Aires F.D. | C1122AAL | Argentina |
| Instituto Alexander Fleming ( Site 1008) | Buenos Aires | Buenos Aires F.D. | C1426ANZ | Argentina |
| Clinica Adventista Belgrano-Oncology ( Site 1004) | Buenos Aires | Buenos Aires F.D. | C1430EGF | Argentina |
| Sanatorio Parque ( Site 1003) | Rosario | Santa Fe Province | S2000DVC | Argentina |
| Hospital Italiano de Córdoba ( Site 1000) | Córdoba | X5004BAL | Argentina |
| CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA-Pesquisa Clínica ( Site 1102) | Fortaleza | Ceará | 60336-232 | Brazil |
| Hospital de Cancer de Pernambuco ( Site 1107) | Recife | Pernambuco | 50040-000 | Brazil |
| Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 1100) | Porto Alegre | Rio Grande do Sul | 91350-200 | Brazil |
| Instituto Joinvilense de Hematologia e Oncologia ( Site 1101) | Joinville | Santa Catarina | 89201-260 | Brazil |
| A. C. Camargo Cancer Center ( Site 1106) | São Paulo | 01509-010 | Brazil |
| IC La Serena Research ( Site 1207) | La Serena | Coquimbo Region | 1720430 | Chile |
| Oncocentro Valdivia ( Site 1201) | Valdivia | Los Ríos Region | 5112129 | Chile |
| FALP-UIDO ( Site 1203) | Santiago | Region M. de Santiago | 7500921 | Chile |
| Oncovida ( Site 1209) | Santiago | Region M. de Santiago | 7500994 | Chile |
| Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 1210) | Santiago | Region M. de Santiago | 8330024 | Chile |
| Instituto Nacional del Cancer-CR Investigación ( Site 1211) | Santiago | Region M. de Santiago | 8380455 | Chile |
| Bradfordhill-Clinical Area ( Site 1202) | Santiago | Region M. de Santiago | 8420383 | Chile |
| Anhui Provincial Hospital-Cancer Chemotherapy Department ( Site 4503) | Hefei | Anhui | 230071 | China |
| Beijing Cancer hospital-intrathoratic deparmtment II ( Site 4510) | Beijing | Beijing Municipality | 100142 | China |
| Beijing Peking Union Medical College Hospital-pneumology department ( Site 4501) | Beijing | Beijing Municipality | 100730 | China |
| Beijing Chest Hospital,Capital Medical University ( Site 4511) | Beijing | Beijing Municipality | 101149 | China |
| Chongqing University Three Gorges Hospital ( Site 4516) | Wanzhou | Chongqing Municipality | 404199 | China |
| Fujian Provincial Cancer Hospital ( Site 4517) | Fuzhou | Fujian | 350014 | China |
| Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 4519) | Guangzhou | Guangdong | 510515 | China |
| Jiangmen Center Hospital ( Site 4509) | Jiangmen | Guangdong | 529030 | China |
| ShenZhen People's Hospital ( Site 4504) | Shenzhen | Guangdong | 518020 | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 4502) | Wuhan | Hubei | 430048 | China |
| The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 4515) | Nanchang | Jiangxi | 330006 | China |
| The First Affiliated Hospital of Xi'an Jiaotong University ( Site 4520) | Xi'an | Shaanxi | 710061 | China |
| Fudan University Shanghai Cancer Center-Oncology ( Site 4512) | Shanghai | Shanghai Municipality | 200032 | China |
| Shanxi Cancer Hospital ( Site 4521) | Taiyuan | Shanxi | 410013 | China |
| Tianjin Chest Hospital ( Site 4518) | Tianjin | Tianjin Municipality | 300051 | China |
| The First Affiliated Hospital, Zhejiang University-Respiratory Department ( Site 4514) | Hangzhou | Zhejiang | 310003 | China |
| Taizhou Hospital of Zhejiang Province ( Site 4508) | Linhai | Zhejiang | 317000 | China |
| Centre Hospitalier de Cornouaille Quimper - Concarneau ( Site 2600) | Quimper | Finistere | 29107 | France |
| Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 2602) | Tours | Indre-et-Loire | 37000 | France |
| Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 2603) | Paris | 75014 | France |
| MEDI-K ( Site 1403) | Guatemala City | 01009 | Guatemala |
| Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 1404) | Guatemala City | 01010 | Guatemala |
| Centro Regional de Sub Especialidades Médicas SA ( Site 1401) | Quetzaltenango | 09001 | Guatemala |
| Centro Medico Integral De Cancerología (CEMIC) ( Site 1400) | Quetzaltenango | 09002 | Guatemala |
| Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2102) | Kecskemét | Bács-Kiskun county | 6000 | Hungary |
| Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 2103) | Szolnok | Jász-Nagykun-Szolnok | 5004 | Hungary |
| Reformatus Pulmonologiai Centrum ( Site 2105) | Törökbálint | Pest County | 2045 | Hungary |
| Semmelweis Egyetem-Pulmonológiai Klinika ( Site 2104) | Budapest | 1083 | Hungary |
| Országos Korányi Pulmonológiai Intézet-VI. Tüdöbelosztály és Bronchológia ( Site 2100) | Budapest | 1121 | Hungary |
| Fujita Health University Hospital ( Site 4406) | Toyoake | Aichi-ken | 470-1192 | Japan |
| Kurume University Hospital ( Site 4412) | Kurume | Fukuoka | 830-0011 | Japan |
| Gunma Prefectural Cancer Center ( Site 4416) | Ōta | Gunma | 373-8550 | Japan |
| National Hospital Organization Hokkaido Cancer Center ( Site 4415) | Sapporo | Hokkaido | 003-0804 | Japan |
| Kanagawa Cardiovascular and Respiratory Center ( Site 4404) | Yokohama | Kanagawa | 236-0051 | Japan |
| Miyagi Cancer Center ( Site 4401) | Natori-shi | Miyagi | 981-1293 | Japan |
| Sendai Kousei Hospital ( Site 4400) | Sendai | Miyagi | 981-0914 | Japan |
| Kurashiki Central Hospital ( Site 4409) | Kurashiki | Okayama-ken | 710-8602 | Japan |
| Kansai Medical University Hospital ( Site 4408) | Hirakata | Osaka | 573-1191 | Japan |
| Osaka Medical and Pharmaceutical University Hospital ( Site 4414) | Takatsuki | Osaka | 569-8686 | Japan |
| Saitama Prefectural Cancer Center ( Site 4402) | Kitaadachi-gun | Saitama | 362-0806 | Japan |
| Shizuoka Cancer Center ( Site 4405) | Sunto-gun, | Shizuoka | 411-8777 | Japan |
| Tochigi Cancer Center ( Site 4417) | Utsunomiya | Tochigi | 320-0834 | Japan |
| Juntendo University Hospital ( Site 4413) | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| National Hospital Organization Kyushu Medical Center ( Site 4411) | Fukuoka | 810-8563 | Japan |
| National Hospital Organization Kyushu Cancer Center ( Site 4410) | Fukuoka | 811-1395 | Japan |
| Osaka International Cancer Institute ( Site 4407) | Osaka | 541-8567 | Japan |
| Nippon Medical School Hospital ( Site 4403) | Tokyo | 113-8603 | Japan |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2800) | Warsaw | Masovian Voivodeship | 02-781 | Poland |
| Warmińsko - Mazurskie Centrum Chorób Płuc w Olsztynie-Oddzial Onkologii z Pododdzialem Chemioterapii ( Site 2802) | Olsztyn | Warmian-Masurian Voivodeship | 10-357 | Poland |
| Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 2801) | Koszalin | West Pomeranian Voivodeship | 75-581 | Poland |
| SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2303) | Florești | Cluj | 407280 | Romania |
| Centrul de Oncologie Sfantul Nectarie-Medical ( Site 2301) | Craiova | Dolj | 200542 | Romania |
| Cabinet Medical Oncomed ( Site 2305) | Timișoara | Timiș County | 300239 | Romania |
| Institutul Oncologic-Oncologie Medicala ( Site 2302) | Cluj-Napoca | 400015 | Romania |
| CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2903) | Port Elizabeth | Eastern Cape | 6055 | South Africa |
| Medical Oncology Centre of Rosebank ( Site 2907) | Johannesburg | Gauteng | 2196 | South Africa |
| Steve Biko Academic Hospital-Medical Oncology ( Site 2904) | Pretoria | Gauteng | 0001 | South Africa |
| Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 2900) | Sandton | Gauteng | 2196 | South Africa |
| The Oncology Centre ( Site 2901) | Durban | KwaZulu-Natal | 4091 | South Africa |
| Cape Town Oncology Trials ( Site 2902) | Cape Town | Western Cape | 7570 | South Africa |
| CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2404) | Santiago de Compostela | La Coruna | 15706 | Spain |
| HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2401) | Madrid | Madrid, Comunidad de | 28009 | Spain |
| Hospital Universitari Vall d'Hebron-Oncology ( Site 2400) | Barcelona | 08035 | Spain |
| Hospital Universitario Juan Ramon Jimenez-Oncología Medica ( Site 2402) | Huelva | 21005 | Spain |
| National Taiwan University Cancer Center (NTUCC) ( Site 4205) | Taipei City | Taipei | 106 | Taiwan |
| Changhua Christian Hospital ( Site 4203) | Changhua | 50006 | Taiwan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 4207) | Kaohsiung City | 807 | Taiwan |
| E-Da hospital ( Site 4208) | Kaohsiung City | 82445 | Taiwan |
| Chang Gung Memorial Hospital at Kaohsiung ( Site 4200) | Kaohsiung City | 83301 | Taiwan |
| National Cheng Kung University Hospital ( Site 4202) | Tainan | 704 | Taiwan |
| National Taiwan University Hospital-Oncology ( Site 4204) | Taipei | 10002 | Taiwan |
| Chulalongkorn University ( Site 4301) | Bangkok | Bangkok | 10330 | Thailand |
| Division of Medical Oncology, Siriraj H ( Site 4303) | Bangkok | Bangkok | 10700 | Thailand |
| Songklanagarind hospital ( Site 4302) | Songkhla | Changwat Songkhla | 90110 | Thailand |
| Maharaj Nakorn Chiang Mai Hospital ( Site 4300) | Chiang Mai | 50200 | Thailand |
| Gulhane Egitim Arastirma Hastanesi-Oncology ( Site 2504) | Ankara | 06010 | Turkey (Türkiye) |
| Hacettepe Universite Hastaneleri-oncology hospital ( Site 2506) | Ankara | 06230 | Turkey (Türkiye) |
| Ankara City Hospital-Medical Oncology ( Site 2501) | Ankara | 06800 | Turkey (Türkiye) |
| TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2502) | Istanbul | 34722 | Turkey (Türkiye) |
| I.E.U. Medical Point Hastanesi-Oncology ( Site 2507) | Izmir | 35575 | Turkey (Türkiye) |
| Memorial Kayseri Hastanesi ( Site 2500) | Kayseri | 38010 | Turkey (Türkiye) |
| İnönü Üniversitesi Turgut Özal Tıp Merkezi-medical oncology depertmant ( Site 2503) | Malatya | 44280 | Turkey (Türkiye) |
| Plain Language Summary | View source |
| FG001 | Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy | Participants with treatment-naïve metastatic NSCLC receive 400 mg pembrolizumab intravenous (IV) infusion in combination with platinum doublet chemotherapy. |
| COMPLETED |
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| NOT COMPLETED |
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All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy | Participants with treatment-naïve metastatic NSCLC receive 790 mg of Pembrolizumab Formulated With Berahyaluronidase Alfa via subcutaneous (SC) injection on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy. |
| BG001 | Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy | Participants with treatment-naïve metastatic NSCLC receive 400 mg pembrolizumab intravenous (IV) infusion in combination with platinum doublet chemotherapy. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| 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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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Cycle 1: Area Under the Curve From Time 0 to 6 Weeks (AUC0-6 Weeks) of Pembrolizumab After the First Dose | AUC0-6 weeks was defined as a measure of pembrolizumab exposure that was calculated as the product of serum drug concentration and time from zero to 6 weeks. Blood samples were collected at pre-specified timepoints to determine AUC0-6 weeks. Per protocol, geometric mean AUC0-6 weeks value of pembrolizumab after the first dose of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and after first dose of pembrolizumab in arm 2 was presented. | All randomized participants who received a dose in Cycle 1 with at least 1 valid postdose pharmacokinetic (PK) sample available in Cycle 1 and for whom a model-based assessment of AUC0-6 weeks could be made. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg·day/mL | Cycle 1: Arm 1: Day 1: Predose and Days 2, 3, 4, 5, 6, 7, 10, 15, 29, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4, 15, 29, and 42 postdose (cycle length = 42 days) |
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| Primary | Cycle 3: Trough Serum Concentration (Ctrough) of Pembrolizumab at Steady State | Ctrough was defined as the lowest serum concentration of pembrolizumab reached at steady state. Blood samples were collected at pre-specified timepoints for the determination of Ctrough. Per protocol, geometric mean Ctrough value of pembrolizumab at steady state of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and of pembrolizumab in arm 2 was presented. | All randomized participants who received a dose in Cycle 1 and Cycle 3 with at least 1 valid postdose PK sample available in Cycle 1 through Cycle 3 and for whom a model-based assessment of Ctrough could be made. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Cycle 3: Arm 1: Day 1: Predose and Days 4, 10, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4 and 42 postdose (cycle length = 42 days) |
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| Secondary | Cycle 1: Maximum Serum Concentration (Cmax) of Pembrolizumab After the First Dose | Cmax was defined as the maximum serum concentration of pembrolizumab reached after first dose. Blood samples were collected at pre-specified timepoints for the determination of Cmax. Per protocol, geometric mean Cmax value of pembrolizumab after the first dose of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and after first dose of pembrolizumab in arm 2 was presented. | All randomized participants who received a dose in Cycle 1 with at least 1 valid postdose PK sample available in Cycle 1 and for whom a model-based assessment of Cmax could be made. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Cycle 1: Arm 1: Day 1: Predose and Days 2, 3, 4, 5, 6, 7, 10, 15, 29, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4, 15, 29, and 42 postdose (cycle length = 42 days) |
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| Secondary | Cycle 1: Trough Serum Concentration (Ctrough) of Pembrolizumab After the First Dose | Ctrough was defined as the lowest serum concentration of pembrolizumab reached after first dose. Blood samples were collected at pre-specified timepoints for the determination of Ctrough. Per protocol, geometric mean Ctrough value of pembrolizumab after the first dose of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and after first dose of pembrolizumab in arm 2 was presented. | All randomized participants who received a dose in Cycle 1 with at least 1 valid postdose PK sample available in Cycle 1 and for whom a model-based assessment of Ctrough could be made. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Cycle 1: Arm 1: Day 1: Predose and Days 2, 3, 4, 5, 6, 7, 10, 15, 29, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4, 15, 29, and 42 postdose (cycle length = 42 days) |
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| Secondary | Cycle 3: Area Under the Curve From Time 0 to 6 Weeks (AUC0-6 Weeks) of Pembrolizumab at Steady State | AUC0-6 weeks was defined as a measure of pembrolizumab exposure that was calculated as the product of serum drug concentration and time from zero to 6 weeks. Blood samples were collected at pre-specified timepoints to determine AUC0-6 weeks. Per protocol, geometric mean AUC0-6 weeks value of pembrolizumab at steady state of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and pembrolizumab in arm 2 was presented. | All randomized participants who received a dose in Cycle 1 and Cycle 3 with at least 1 valid postdose PK sample available in Cycle 1 through Cycle 3 and for whom a model-based assessment of AUC0-6 weeks could be made. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg·day/mL | Cycle 3: Arm 1: Day 1: Predose and Days 4, 10, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4 and 42 postdose (cycle length = 42 days) |
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| Secondary | Cycle 3: Maximum Serum Concentration (Cmax) of Pembrolizumab at Steady State | Cmax was defined as the maximum serum concentration of pembrolizumab reached at steady state. Blood samples were collected at pre-specified timepoints to determine Cmax. Per protocol, geometric mean Cmax value of pembrolizumab at steady state of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and pembrolizumab in arm 2 was presented. | All randomized participants who received a dose in Cycle 1 and Cycle 3 with at least 1 valid postdose PK sample available in Cycle 1 through Cycle 3 and for whom a model-based assessment of Cmax could be made. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Cycle 3: Arm 1: Day 1: Predose and Days 4, 10, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4 and 42 postdose (cycle length = 42 days) |
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| Secondary | Number of Participants Who Test Positive for Anti-Drug Antibodies (ADAs) for Pembrolizumab | Blood samples were collected at designated time points for the determination of the presence or absence of anti-pembrolizumab antibodies. Per protocol, the number of participants who developed anti pembrolizumab antibodies were reported. | Not Posted | Predose and Postdose on Day 1 of Cycles 1 through 18 (up to approximately 28 months). Each cycle is 6 weeks. | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | ORR was defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experienced CR or PR as assessed by Blinded Independent Central Review (BICR) were presented. | Not Posted | Up to approximately 28 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR were presented. | Not Posted | Up to approximately 28 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from randomization to death due to any cause. | Not Posted | Up to approximately 28 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR were presented. | Not Posted | Up to approximately 28 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experienced at Least One Adverse Event (AE) | An AE was 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 number of participants who experienced at least one AE were reported . | Not Posted | Up to approximately 28 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE) | 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. The number of participants who discontinue study treatment due to an AE will be reported for Arms 1 and 2. | Not Posted | Up to approximately 28 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core30 (QLQ-C30) Combined Global Health Status/Quality of Life (Items 29 & 30) Scale Combined Score | EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. Per protocol, the change from baseline in GHS and QoL combined score was presented. | Not Posted | Baseline and Week 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Physical Functioning (EORTC-QLQ-C30 Items 1-5) Score | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score was presented. | Not Posted | Baseline and Week 24 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Role Functioning Score-Items 6 and 7 | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and "Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. Higher scores indicate a better level of role functioning. Change from baseline in the EORTC QLQ-C30 role functioning (Items 6-7) combined score was presented. | Not Posted | Baseline and Week 24 | Participants |
Up to approximately 16 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) include all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" & "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy | Participants with treatment-naïve metastatic NSCLC receive 790 mg of Pembrolizumab Formulated With Berahyaluronidase Alfa via subcutaneous (SC) injection on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy. | 61 | 251 | 98 | 251 | 236 | 251 |
| EG001 | Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy | Participants with treatment-naïve metastatic NSCLC receive 400 mg pembrolizumab intravenous (IV) infusion in combination with platinum doublet chemotherapy. | 37 | 126 | 51 | 126 | 123 | 126 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Adrenal insufficiency | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
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| Immune-mediated hypophysitis | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Enterocolitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Gastric perforation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Gastric ulcer | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Hiatus hernia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Immune-mediated enterocolitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Intestinal perforation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Neutropenic colitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Death | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Multiple organ dysfunction syndrome | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Bile duct stone | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
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| Hepatic failure | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
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| Abdominal infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Abdominal sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| COVID-19 pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Device related sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Diarrhoea infectious | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Empyema | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Infectious pleural effusion | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Large intestine infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Lung abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Myiasis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Neutropenic sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Parotitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Pneumonia bacterial | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Pyelonephritis acute | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Soft tissue infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Craniofacial fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Peripheral nerve injury | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
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| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
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| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Schwannoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
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| Ataxia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Dermatitis exfoliative | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Arterial thrombosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 27.0 | Systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
The results of this study may be published or presented at scientific meetings. The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. Any information identified by the Sponsor as confidential must be deleted prior to submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| Jul 2, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| C582435 | pembrolizumab |
| D000069585 | Filgrastim |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D001685 | Biological Factors |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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|
|
|
|
|
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