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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003300-23 | EudraCT Number |
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| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
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The purpose of this study was to demonstrate superiority of treatment with avelumab versus continuation of first-line chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy + Best Supportive Care (BSC) | Experimental | In Maintenance Phase, participants continued the same regimen of oxaliplatin-fluoropyrimidine doublet chemotherapy (oxaliplatin + 5FU/LV or oxaliplatin + capecitabine) as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. Participants who were not deemed eligible to receive chemotherapy at the dose and schedule specified above received BSC alone once every 3 weeks. BSC was defined as treatment administered with the intent to maximize quality of life without a specific antineoplastic regimen and was based on Investigator's discretion. |
|
| Avelumab | Experimental | In Maintenance phase, participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity or discontinuation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avelumab | Drug | Maintenance Phase: Intravenous (IV) infusion (10 mg/kg over 1 hour) once every 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall Survival was defined as the time from randomization to the date of death due to any cause. For participants who were still alive at the time of data analysis or who were lost to follow-up, OS time was censored at the date of last contact. OS was measured using Kaplan-Meier (KM) estimates. | From randomization into maintenance phase up to 1276 days |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) by Independent Review Committee (IRC) | The PFS time was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause (whichever occurs first). PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as per IRC. PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | EMD Serono Research & Development Institute, Inc. a business of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Blood & Cancer Center | Bakersfield | California | 93309 | United States | ||
| Virginia Crosson Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35623069 | Derived | Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304. | |
| 33197226 | Derived | Moehler M, Dvorkin M, Boku N, Ozguroglu M, Ryu MH, Muntean AS, Lonardi S, Nechaeva M, Bragagnoli AC, Coskun HS, Cubillo Gracian A, Takano T, Wong R, Safran H, Vaccaro GM, Wainberg ZA, Silver MR, Xiong H, Hong J, Taieb J, Bang YJ. Phase III Trial of Avelumab Maintenance After First-Line Induction Chemotherapy Versus Continuation of Chemotherapy in Patients With Gastric Cancers: Results From JAVELIN Gastric 100. J Clin Oncol. 2021 Mar 20;39(9):966-977. doi: 10.1200/JCO.20.00892. Epub 2020 Nov 16. |
| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
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Overall, 1284 participants were screened for this study. Of which 799 participants received at least 1 dose in the Induction Phase, 499 participants were randomized into maintenance phase of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemotherapy + Best Supportive Care (BSC) | Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m^2 or 400 mg/m^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance Phase, participants continued the same regimen of oxaliplatin-fluoropyrimidine doublet chemotherapy (oxaliplatin + 5FU/Leucovorin (LV) or oxaliplatin + capecitabine) as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. Participants who were not deemed eligible to receive chemotherapy at the dose and schedule specified above received BSC alone once every 3 weeks. BSC was defined as treatment administered with the intent to maximize quality of life without a specific antineoplastic regimen and was based on Investigator's discretion. |
| 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 | Yes | No | No | Study Protocol | Jul 17, 2019 | Nov 2, 2021 |
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| Oxaliplatin | Drug | Induction Phase: Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin followed by 5-Fluorouracil every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks up to 12 weeks. Maintenance Phase: Participants were continued the same regimen of chemotherapy as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. |
|
| 5-Fluorouracil | Drug | Induction Phase: 5-Fluorouracil was administered at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 (or) 5-FU at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Days 1 and 2) along with oxaliplatin and leucovorin every 2 weeks up to 12 weeks. Maintenance Phase: Participants were continued the same regimen of chemotherapy as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. |
|
| Leucovorin | Drug | Induction Phase: Leucovorin was administered at a dose of 200 mg/m^2 IV (or) Leucovorin 400 mg/m^2 IV on Day 1 along with oxaliplatin and 5-FU every 2 weeks up to 12 weeks. Maintenance Phase: Participants were continued the same regimen of chemotherapy as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. |
|
| Capecitabine | Drug | Induction Phase: Capecitabine was administered at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks along with oxaliplatin up to 12 weeks. Maintenance Phase: Participants were continued the same regimen of chemotherapy as they received during the Induction Phase every 3 weeks until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. |
|
| Best supportive care | Other | Treatment administered with the intent to maximize Quality of Life (QoL) without a specific antineoplastic regimen. These may include for example antibiotics, analgesics, antiemetics, thoracentesis, paracentesis, blood transfusions, nutritional support (including jejunostomy), and focal external-beam radiation for control of pain, cough, dyspnea, or bleeding. Best supportive care were administered per institutional guidelines and participants were visit the clinic every 3 weeks. |
|
| Oxaliplatin | Drug | Induction Phase: Oxaliplatin will be administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin followed by 5-Fluorouracil every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks up to 12 weeks. |
|
| 5-Fluorouracil | Drug | Induction Phase: 5-Fluorouracil will be administered at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 (or) 5-FU at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Days 1 and 2) along with oxaliplatin and leucovorin every 2 weeks up to 12 weeks. |
|
| Leucovorin | Drug | Induction Phase: Leucovorin will be administered at a dose of 200 mg/m^2 IV (or) Leucovorin 400 mg/m^2 IV on Day 1 along with oxaliplatin and 5-FU every 2 weeks up to 12 weeks. |
|
| Capecitabine | Drug | Induction Phase: Capecitabine will be administered at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks along with oxaliplatin up to 12 weeks. |
|
| From randomization into maintenance phase up to 1276 days |
| Best Overall Response (BOR) by Investigator Assessment | BOR was determined by RECIST v1.1 per Investigator assessment and defined as best-confirmed response of any of following: complete response (CR), partial response (PR), stable disease (SD) and PD recorded from date of randomization until disease progression or recurrence. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in SLD of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or appearance of 1 or more new lesions. PR or CR confirmed at a subsequent tumor assessment, not sooner than 5 weeks after initial documentation or at an assessment later than the next assessment after the initial documentation of PR or CR. SD confirmed at least 6 weeks after randomization. Confirmed PD equal to progression <=2 weeks after date of randomization. | From randomization into maintenance phase up to 1276 days |
| Objective Response Rate (ORR) by Investigator Assessment | The ORR defined as the percentage of all randomized participants with a confirmed best overall response (BOR) of partial response (PR),or complete response (CR) according to RECIST v1.1 and as per Investigator assessment. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in sum of longest diameter (SLD) of all lesions. | From randomization into maintenance phase up to 1276 days |
| Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | EQ-5D-5L is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive overall composite health state index score, with scores ranging from -0.594 to 1. A higher score indicates better health state. | Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks) |
| Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | EQ-5D-5L is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. | Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks) |
| Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnoea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact. The EORTC QLQ-C30 GHS/QoL score ranges from 0 to 100; High score indicates better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL. | Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks) |
| Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) supplements the EORTC QLQ-C30 to assess symptoms and treatment-related side effects commonly reported in participants. There are 22 questions which comprise 5 scales (dysphagia, pain, reflux symptom, dietary restrictions, and anxiety) and 4 single items (dry mouth, hair loss, taste, body image). Most questions use 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms. | Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks) |
| Maintenance Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03) | Adverse event (AE) was defined as any untoward medical occurrence in a participant, which does not necessarily have causal relationship with treatment. A serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in participant hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug. TEAEs included both serious TEAEs and non-serious TEAEs. Number of participants with TEAEs and serious TEAEs were reported. | From randomization into maintenance phase up to 1276 days |
| Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values | Blood samples were collected for the analysis of following hematology parameters: lymphocyte count, neutrophil count, white blood cells, platelet count, lipase, serum amylase, creatinine phosphokinase and creatinine. The hematology parameters were graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case (Grade 4) post Baseline is presented. Only those participants with increase to grade 4 have been presented. | From baseline up to 1276 days |
| Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs | Vital signs assessment included Systolic blood pressure (SBP), Diastolic blood pressure (DBP) and Pulse Rate (PR). Number of Participants with any potentially clinically significant abnormalities in vital signs were reported. Clinical significance was determined by the investigator. | From randomization into maintenance phase up to 1276 days |
| Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | ECG parameters included heart rate, pulse rate intervals, QRS interval, QT interval corrected based on Fridericia's formula (QTcF) intervals and QTcB intervals. Clinical significance was determined by the investigator. Number of participants with potentially clinically significant ECG abnormalities were reported. | From randomization into maintenance phase up to 1276 days |
| Maintenance Phase: Number of Participants With Shift in Eastern Cooperative Oncology Group (ECOG) Performance Status Score to 1 or Higher Than 1 | ECOG PS score is widely used by doctors and researchers to assess how a participants' disease is progressing, and is used to assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. The score ranges from Grade 0 to Grade 5, where Grade 0 = Fully active, able to carry on all pre-disease performance without restriction, Grade 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (like light house work, office work), Grade 2 = Ambulatory and capable of all self-care but unable to carry out any work activities, Grade 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours and Grade 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair, Grade 5 = Death. Number of participants with shift in ECOG PS Score to 1 or Higher Than 1 were reported. | From randomization into maintenance phase up to 1276 days |
| Fullerton |
| California |
| 92835 |
| United States |
| UCLA Medical Center | Los Angeles | California | 90095 | United States |
| Desert Hematology Oncology Medical Group, Inc. | Rancho Mirage | California | 92262 | United States |
| Sansum Clinic | Santa Barbara | California | 93105 | United States |
| Trio - Central Coast Medical Oncology Corporation | Santa Maria | California | 93454 | United States |
| Norwalk Hospital | Norwalk | Connecticut | 6856 | United States |
| UF Health Cancer Center Orlando | Orlando | Florida | 32806 | United States |
| Memorial West Cancer Institute | Pembroke Pines | Florida | 33028 | United States |
| University of South Florida - Parent | Tampa | Florida | 33606 | United States |
| Oncology Specialists, S.C. | Park Ridge | Illinois | 60068 | United States |
| Franciscan St. Francis Health Cancer Center | Indianapolis | Indiana | 46237 | United States |
| Cedar Rapids Oncology Project | Cedar Rapids | Iowa | 52403 | United States |
| Cotton-O'Neil Clinical Research Center, Hematology and Oncology | Topeka | Kansas | 66604 | United States |
| University of Kansas Medical Center Research Institute, Inc. | Westwood | Kansas | 66205 | United States |
| Virginia Piper Cancer Institute | Minneapolis | Minnesota | 55407 | United States |
| Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | United States |
| Mount Sinai - PRIME | Jamaica | New York | 11432 | United States |
| Clinical Research Alliance, Inc | New York | New York | 10021 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| UC Health Clinical Trials Office | Cincinnati | Ohio | 45206 | United States |
| TriHealth Hatton Institute | Cincinnati | Ohio | 45220 | United States |
| Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center | Columbus | Ohio | 43219 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| St. Luke's Hospital | Bethlehem | Pennsylvania | 18015 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Greenville Hospital System University Medical Center (ITOR) | Greenville | South Carolina | 29605 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390-9179 | United States |
| Oncology Consultants, P.A. | Houston | Texas | 77024 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Baylor Scott & White Health | Temple | Texas | 76508 | United States |
| University of Washington - Seattle Cancer Care Alliance | East Seattle | Washington | 98109 | United States |
| Northwest Medical Specialties, PLLC | Tacoma | Washington | 98405 | United States |
| Wenatchee Valley Hospital & Clinics | Wenatchee | Washington | 98801 | United States |
| St George Hospital | Kogarah | New South Wales | 2217 | Australia |
| Royal North Shore Hospital | St Leonards | New South Wales | 2065 | Australia |
| Greenslopes Private Hospital | Greenslopes | Queensland | 4120 | Australia |
| Royal Brisbane and Women's Hospital | Herston | Queensland | 4006 | Australia |
| Flinders Medical Centre | Bedford Park | South Australia | 5042 | Australia |
| Lyell McEwin Hospital | Elizabeth Vale | South Australia | 5112 | Australia |
| Royal Hobart Hospital | Hobart | Tasmania | 7000 | Australia |
| Ballarat Base Hospital | Ballarat | Victoria | 3350 | Australia |
| Bendigo Hospital | Bendigo | Victoria | 3550 | Australia |
| Monash Medical Centre Clayton | Bentleigh | Victoria | 8120 | Australia |
| Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Border Medical Oncology | Wodonga | Victoria | 3690 | Australia |
| Fiona Stanley Hospital | Murdoch | Western Australia | 6150 | Australia |
| Hospital Infanta Cristina | Badajós | Badajoz | 06080 | Brazil |
| NOB - Núcleo de Oncologia da Bahia | Salvador | Estado de Bahia | 40170-110 | Brazil |
| Hospital São Lucas da PUCRS | Ijuí | Rio Grande do Sul | 98700-000 | Brazil |
| Hospital Bruno Born | Lajeado | Rio Grande do Sul | 95900-000 | Brazil |
| Oncosinos - Clínica de Oncologia - Hospital Regina | Novo Hamburgo | Rio Grande do Sul | 93510-250 | Brazil |
| Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Hospital São Lucas da PUCRS | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Hospital de Câncer de Barretos-Fundação Pio XII | Barretos | São Paulo | 14784-400 | Brazil |
| IMV - Instituto De Medicina Vascular Hospital Mae de Deus | Porto Alegre | São Paulo | 90110-270 | Brazil |
| CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia | Santo André | São Paulo | 09060-650 | Brazil |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira | São Paulo | São Paulo | 01246-000 | Brazil |
| Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| The Royal Victoria Hospital | Barrie | Ontario | L4M 6M2 | Canada |
| Humber River Hospital | Toronto | Ontario | M3M 0B2 | Canada |
| Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada |
| Cité de la Santé de Laval | Laval | Quebec | H7M 3L9 | Canada |
| McGill University - Dept. Oncology Clinical Research Program | Montreal | Quebec | H2W 1S6 | Canada |
| Centre Antoine Lacassagne | Nice | Alpes Maritimes | 06189 | France |
| Hôpital de la Timone | Marseille | Bouches Du Rhone | 13385 | France |
| Hôpital Morvan | Brest | Brittany Region | 29200 | France |
| Centre Georges François Leclerc | Dijon | Côte-d'Or | 21079 | France |
| CHU Besancon - Hopital Jean Minjoz | Besançon | Doubs | 25030 | France |
| CHU Bordeaux | Bordeaux | Gironde | 33076 | France |
| CHU de Toulouse - Hôpital Rangueil | Toulouse | Haute Garonne | 31059 | France |
| CRLCC Eugene Marquis | Rennes | Ille Et Vilaine | 35042 | France |
| CHU Tours - Hôpital Trousseau | Chambray-lès-Tours | Indre Et Loire | 37170 | France |
| ICO - Site René Gauducheau | Angers | Maine Et Loire | 49933 | France |
| Hôpital Européen Georges Pompidou | Paris | Paris | 75015 | France |
| Hôpital Cochin | Paris | Paris | 75679 | France |
| CHU Clermont Ferrand | Clermont-Ferrand | Puy De Dome | 63003 | France |
| Clinique Victor Hugo - Centre Jean Bernard | Le Mans | Sarthe | 72015 | France |
| Klinikum Esslingen GmbH | Esslingen A. N. | Baden-Wurttemberg | 73730 | Germany |
| SLK-Kliniken Heilbronn GmbH | Heilbronn | Baden-Wurttemberg | 74078 | Germany |
| Klinikum Bogenhausen | Munich | Bavaria | 81925 | Germany |
| Leopoldina Krankenhaus Schweinfurt | Schweinfurt | Bavaria | 97422 | Germany |
| Krankenhaus Nordwest GmbH | Frankfurt am Main | Hesse | 60488 | Germany |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | Mainz | Rhineland-Palatinate | 55131 | Germany |
| Onkologische Schwerpunktpraxis Eppendorf | Hamburg | 20249 | Germany |
| Marienkrankenhaus Hamburg | Hamburg | 22087 | Germany |
| Pecsi Tudomanyegyetem | Pécs | Baranya | 7624 | Hungary |
| Petz Aladar Megyei Oktato Korhaz | Győr | Győr-Moson-Sopron | 9024 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | Hajdú-Bihar | 4032 | Hungary |
| Magyar Honvedseg Egeszsegugyi | Budapest | 1062 | Hungary |
| SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz | Nyíregyháza | 4400 | Hungary |
| Tolna Megyei Balassa Janos Korhaz | Szekszárd | 7100 | Hungary |
| Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet | Szolnok | 5000 | Hungary |
| Zala Megyei Szent Rafael Korhaz | Zalaegerszeg | 8900 | Hungary |
| Presidio Ospedaliero Garibaldi Nesima | Catania | 95100 | Italy |
| Azienda Socio Sanitaria Territoriale di Cremona (Istituti Ospitalieri di Cremona) | Cremona | 26100 | Italy |
| Azienda Ospedaliera Universitaria Careggi | Florence | 50141 | Italy |
| Ospedale San Raffaele | Milan | 20132 | Italy |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | 20133 | Italy |
| IEO Istituto Europeo di Oncologia | Milan | 20141 | Italy |
| Istituto Nazionale Tumori Fondazione G. Pascale | Naples | 80131 | Italy |
| Seconda Università degli Studi di Napoli | Naples | 80131 | Italy |
| IOV - Istituto Oncologico Veneto IRCCS | Padova | 35128 | Italy |
| Ospedale degli Infermi | Rimini | 47923 | Italy |
| Università Campus Bio-Medico di Roma | Roma | 00128 | Italy |
| Azienda Ospedaliera S. Maria Di Terni | Terni | 5100 | Italy |
| Azienda Ospedaliero-Universitaria Santa Maria della Misericordia | Udine | 33100 | Italy |
| Chiba Cancer Center | Chiba | Chiba | 260-8717 | Japan |
| Kagawa University Hospital | Kita-gun | Kagawa-ken | 761-0793 | Japan |
| Kanagawa Cancer Center | Yokohama | Kanagawa | 241-8515 | Japan |
| Kumamoto University Hospital | Kumamoto | Kumamoto | 860-8556 | Japan |
| Tohoku University Hospital | Sendai | Miyagi | 980-8574 | Japan |
| Niigata Cancer Center Hospital | Niigata | Niigata | 951-8566 | Japan |
| Oita University Hospital | Yufu-shi | Oita Prefecture | 879-5593 | Japan |
| Izumi Municipal Hospital | Izumi-shi | Osaka | 594-0071 | Japan |
| Kindai University Hospital | Sayama | Osaka | 589-8511 | Japan |
| Saitama Medical University International Medical Center | Hidaka-shi | Saitama | 350-1298 | Japan |
| Saitama Cancer Center | Kitaadachi-gun | Saitama | 362-0806 | Japan |
| Tochigi Cancer Center | Utsunomiya | Tochigi | 320-0834 | Japan |
| Nat Cancer Ctr Hosp | Chūōku | Tokyo-To | 104-0045 | Japan |
| Toranomon Hospital | Minatoku | Tokyo-To | 105-8470 | Japan |
| Kagoshima University Medical And Dental Hospital | Kagoshima | 890-8520 | Japan |
| Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca | Cluj-Napoca | Cluj | 400015 | Romania |
| S.C Radiotherapy Center Cluj S.R.L | Comuna Floresti | Cluj | 407280 | Romania |
| S.C Centrul de Oncologie Sf. Nectarie S.R.L | Craiova | Dolj | 200347 | Romania |
| Spital Lotus SRL | Ploieşti | Prahova | 100011 | Romania |
| S.C Oncocenter Oncologie Clinica S.R.L | Timișoara | Timiș County | 300210 | Romania |
| S.C Oncomed S.R.L | Timișoara | Timiș County | 300239 | Romania |
| S.C Oncopremium Team S.R.L | Baia Mare | 430291 | Romania |
| Institutul Clinic Fundeni | Bucharest | 022328 | Romania |
| Spitalul Clinic Coltea | Bucharest | 030171 | Romania |
| Hifu Terramed Conformal SRL | Bucharest | 031864 | Romania |
| Institutul Regional de Oncologie Iasi | Iași | 700483 | Romania |
| Pavlov First Saint Petersburg State Medical University | Saint Petersburg | Leningrado | 197022 | Russia |
| FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov" | Saint Petersburg | Leningrado | 197758 | Russia |
| SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary" | Arkhangelsk | 163045 | Russia |
| LLC Evimed | Chelyabinsk | 454048 | Russia |
| RBIH "Ivanovo Regional Oncological Dispensary" | Ivanovo | 153040 | Russia |
| SBIH " Clinical Oncological Dispensary # 1" | Krasnodar | 350040 | Russia |
| FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin" | Moscow | 115478 | Russia |
| BHI of Omsk region "Clinical Oncology Dispensary" | Omsk | 644013 | Russia |
| SBIH of Stavropol territory "Pyatigorsk Oncological Dispensary" | Pyatigorsk | 357502 | Russia |
| SPb SBIH "City Clinical Oncological Dispensary" | Saint Petersburg | 197022 | Russia |
| National Cancer Center | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Chonnam National University Hwasun Hospital | Hwasun-gun | Jeollanam-do | 58128 | South Korea |
| Keimyung University Dongsan Hospital | Daegu | Jung-gu | 41931 | South Korea |
| Chungbuk National University Hospital | Cheongju-si | North Chungcheong | 28644 | South Korea |
| Inje University Haeundae Paik Hospital | Busan | 48108 | South Korea |
| Kyungpook National University Medical Center | Daegu | 41404 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | 06591 | South Korea |
| Korea University Anam Hospital | Seoul | 2841 | South Korea |
| Seoul National University Hospital | Seoul | 3080 | South Korea |
| Yonsei University Health System | Seoul | 3722 | South Korea |
| Hospital General Universitario de Elche | Elche | Alicante | 03203 | Spain |
| ICO l´Hospitalet - Hospital Duran i Reynals | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
| Corporacio Sanitaria Parc Tauli | Sabadell | Barcelona | 08208 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic i Provincial de Barcelona | Barcelona | 08036 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 8025 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28007 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitario HM Madrid Sanchinarro | Madrid | 28050 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | 83301 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Taipei | 10048 | Taiwan |
| Mackay Memorial Hospital | Taipei | 104 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Chang Gung Memorial Hospital, Linkou | Taoyuan | 33305 | Taiwan |
| King Chulalongkorn Memorial Hospital | Patumwan | Bangkok | 10330 | Thailand |
| Maharaj Nakorn Chiang Mai Hospital | Muang | Chiang Mai | 50200 | Thailand |
| Siriraj Hospital | Bangkok | 10700 | Thailand |
| Acibadem Adana Hospital | Adana | 01130 | Turkey (Türkiye) |
| Adana Numune Training and Research Hospital | Adana | 1240 | Turkey (Türkiye) |
| Hacettepe University Medical Faculty | Ankara | 06100 | Turkey (Türkiye) |
| Akdeniz University Medical Faculty | Antalya | 7058 | Turkey (Türkiye) |
| Dicle University, Medical faculty | Diyarbakır | 21080 | Turkey (Türkiye) |
| Istanbul University Cerrahpasa Medical Faculty | Istanbul | 34098 | Turkey (Türkiye) |
| Marmara University Pendik Research and Training Hospital | Istanbul | 34340 | Turkey (Türkiye) |
| Kocaeli University Medical Faculty | Kocaeli | 41380 | Turkey (Türkiye) |
| Konya Necmettin Erbakan University Meram Medical Faculty | Konya | 42100 | Turkey (Türkiye) |
| Inonu Uni. Med. Fac. | Malatya | 44280 | Turkey (Türkiye) |
| Mersin University Medical Faculty | Mersin | 33169 | Turkey (Türkiye) |
| Derriford Hospital | Torquay | Devon | TQ2 7AA | United Kingdom |
| Barts Hospital | London | Greater London | EC1A 7BE | United Kingdom |
| University College London Hospitals | London | Greater London | WC1E 6AG | United Kingdom |
| The Christie | Manchester | Greater Manchester | M20 4BX | United Kingdom |
| The Clatterbridge Cancer Centre | Metropolitan Borough of Wirral | Merseyside | CH63 4JY | United Kingdom |
| Mount Vernon Hospital | Northwood | Middlesex | HA6 2RN | United Kingdom |
| Royal Surrey County Hospital | Guildford | Surrey | GU2 7XX | United Kingdom |
| Ninewells Hospital | Dundee | Tayside Region | DD1 9SY | United Kingdom |
| St James's University Hospital | Leeds | West Yorkshire | LS9 7TF | United Kingdom |
| US Medical Information website, Medical Resources | View source |
| FG001 | Avelumab | Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m^2 or 400 mg/m^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity or discontinuation. |
| Safety-Maintenance Analysis Set |
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| COMPLETED |
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| NOT COMPLETED |
|
Full analysis set included all randomized participants included in treatment arm to which they were randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Chemotherapy + Best Supportive Care (BSC) | Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m^2 or 400 mg/m^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance Phase, participants continued the same regimen of oxaliplatin-fluoropyrimidine doublet chemotherapy (oxaliplatin + 5FU/Leucovorin (LV) or oxaliplatin + capecitabine) as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. Participants who were not deemed eligible to receive chemotherapy at the dose and schedule specified above received BSC alone once every 3 weeks. BSC was defined as treatment administered with the intent to maximize quality of life without a specific antineoplastic regimen and was based on Investigator's discretion. |
| BG001 | Avelumab | Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m^2 or 400 mg/m^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity or discontinuation. |
| 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/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 | Overall Survival (OS) | Overall Survival was defined as the time from randomization to the date of death due to any cause. For participants who were still alive at the time of data analysis or who were lost to follow-up, OS time was censored at the date of last contact. OS was measured using Kaplan-Meier (KM) estimates. | Full analysis set included all randomized participants included in treatment arm to which they were randomized. | Posted | Median | 95% Confidence Interval | months | From randomization into maintenance phase up to 1276 days |
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| Secondary | Progression Free Survival (PFS) by Independent Review Committee (IRC) | The PFS time was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause (whichever occurs first). PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as per IRC. PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates. | Full analysis set included all randomized participants included in treatment arm to which they were randomized. | Posted | Median | 95% Confidence Interval | months | From randomization into maintenance phase up to 1276 days |
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| Secondary | Best Overall Response (BOR) by Investigator Assessment | BOR was determined by RECIST v1.1 per Investigator assessment and defined as best-confirmed response of any of following: complete response (CR), partial response (PR), stable disease (SD) and PD recorded from date of randomization until disease progression or recurrence. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in SLD of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or appearance of 1 or more new lesions. PR or CR confirmed at a subsequent tumor assessment, not sooner than 5 weeks after initial documentation or at an assessment later than the next assessment after the initial documentation of PR or CR. SD confirmed at least 6 weeks after randomization. Confirmed PD equal to progression <=2 weeks after date of randomization. | Full analysis set included all randomized participants included in treatment arm to which they were randomized. | Posted | Count of Participants | Participants | From randomization into maintenance phase up to 1276 days |
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| Secondary | Objective Response Rate (ORR) by Investigator Assessment | The ORR defined as the percentage of all randomized participants with a confirmed best overall response (BOR) of partial response (PR),or complete response (CR) according to RECIST v1.1 and as per Investigator assessment. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in sum of longest diameter (SLD) of all lesions. | Full analysis set included all randomized participants included in treatment arm to which they were randomized. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization into maintenance phase up to 1276 days |
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| Secondary | Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score up to Safety Follow-up (Up to 152.3 Weeks) | EQ-5D-5L is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive overall composite health state index score, with scores ranging from -0.594 to 1. A higher score indicates better health state. | Health-related quality of life (HRQoL) analysis set included randomized participants who had 1 Maintenance Phase Baseline HRQoL assessment and had at least 1 post-Maintenance Phase Baseline HRQoL questionnaire completed. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signified those participants who were evaluable for the specified category at given time points. | Posted | Mean | Standard Deviation | Units on Scale | Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks) |
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| Secondary | Change From Baseline in European Quality of Life 5-dimensions Health Outcome Questionnaire Through Visual Analogue Scale up to Safety Follow-up (Up to 152.3 Weeks) | EQ-5D-5L is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine. | Health-related quality of life (HRQoL) analysis set included randomized participants who had 1 Maintenance Phase Baseline HRQoL assessment and had at least 1 post-Maintenance Phase Baseline HRQoL questionnaire completed. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signified those participants who were evaluable for the specified category at given time points. | Posted | Mean | Standard Deviation | Millimeter | Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks) |
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| Secondary | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score up to Safety Follow-up (Up to 152.3 Weeks) | European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnoea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact. The EORTC QLQ-C30 GHS/QoL score ranges from 0 to 100; High score indicates better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL. | Health-related quality of life (HRQoL) analysis set included randomized participants who had 1 Maintenance Phase Baseline HRQoL assessment and had at least 1 post-Maintenance Phase Baseline HRQoL questionnaire completed. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signified those participants who were evaluable for the specified category at given time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks) |
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| Secondary | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) Questionnaire Scores up to Safety Follow-up (Up to 152.3 Weeks) | European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22 ) supplements the EORTC QLQ-C30 to assess symptoms and treatment-related side effects commonly reported in participants. There are 22 questions which comprise 5 scales (dysphagia, pain, reflux symptom, dietary restrictions, and anxiety) and 4 single items (dry mouth, hair loss, taste, body image). Most questions use 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms. | Health-related quality of life (HRQoL) analysis set included randomized participants who had 1 Maintenance Phase Baseline HRQoL assessment and had at least 1 post-Maintenance Phase Baseline HRQoL questionnaire completed. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number Analyzed" signified those participants who were evaluable for the specified category at given time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 3/4, Week 7, Week 13, Week 19, Week 25, Week 31, Week 37, Week 43, Week 49, Week 55, Week 61, Week 67, End of Treatment ( EOT up to 148 weeks) and Safety Follow-up (Up to 152.3 Weeks) |
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| Secondary | Maintenance Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03) | Adverse event (AE) was defined as any untoward medical occurrence in a participant, which does not necessarily have causal relationship with treatment. A serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in participant hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug. TEAEs included both serious TEAEs and non-serious TEAEs. Number of participants with TEAEs and serious TEAEs were reported. | Safety-Maintenance Analysis Set included all participants who were administered any dose of the maintenance phase study medication or participants randomized to the chemotherapy arm who are designated to receive BSC only. Participants included in the treatment arm according to study treatment actually received. | Posted | Count of Participants | Participants | From randomization into maintenance phase up to 1276 days |
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| Secondary | Maintenance Phase: Number of Participants With Grade Change From Baseline to Worst On-Treatment Grade 4 Hematology Values | Blood samples were collected for the analysis of following hematology parameters: lymphocyte count, neutrophil count, white blood cells, platelet count, lipase, serum amylase, creatinine phosphokinase and creatinine. The hematology parameters were graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case (Grade 4) post Baseline is presented. Only those participants with increase to grade 4 have been presented. | Safety-Maintenance Analysis (SMA) Set included all participants who were administered any dose of the maintenance phase study medication or participants randomized to the chemotherapy arm who are designated to receive BSC only. Participants included in the treatment arm according to study treatment actually received. | Posted | Count of Participants | Participants | From baseline up to 1276 days |
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| Secondary | Maintenance Phase: Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs | Vital signs assessment included Systolic blood pressure (SBP), Diastolic blood pressure (DBP) and Pulse Rate (PR). Number of Participants with any potentially clinically significant abnormalities in vital signs were reported. Clinical significance was determined by the investigator. | Safety-Maintenance Analysis Set included all participants who were administered any dose of the maintenance phase study medication or participants randomized to the chemotherapy arm who are designated to receive BSC only. Participants included in the treatment arm according to study treatment actually received. | Posted | Count of Participants | Participants | From randomization into maintenance phase up to 1276 days |
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| Secondary | Maintenance Phase: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | ECG parameters included heart rate, pulse rate intervals, QRS interval, QT interval corrected based on Fridericia's formula (QTcF) intervals and QTcB intervals. Clinical significance was determined by the investigator. Number of participants with potentially clinically significant ECG abnormalities were reported. | Safety-Maintenance Analysis Set included all participants who were administered any dose of the maintenance phase study medication or participants randomized to the chemotherapy arm who are designated to receive BSC only. Participants included in the treatment arm according to study treatment actually received. | Posted | Count of Participants | Participants | From randomization into maintenance phase up to 1276 days |
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| Secondary | Maintenance Phase: Number of Participants With Shift in Eastern Cooperative Oncology Group (ECOG) Performance Status Score to 1 or Higher Than 1 | ECOG PS score is widely used by doctors and researchers to assess how a participants' disease is progressing, and is used to assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. The score ranges from Grade 0 to Grade 5, where Grade 0 = Fully active, able to carry on all pre-disease performance without restriction, Grade 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (like light house work, office work), Grade 2 = Ambulatory and capable of all self-care but unable to carry out any work activities, Grade 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours and Grade 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair, Grade 5 = Death. Number of participants with shift in ECOG PS Score to 1 or Higher Than 1 were reported. | Safety-Maintenance Analysis Set included all participants who were administered any dose of the maintenance phase study medication or participants randomized to the chemotherapy arm who are designated to receive BSC only. Participants included in the treatment arm according to study treatment actually received. | Posted | Count of Participants | Participants | From randomization into maintenance phase up to 1276 days |
|
From randomization into maintenance phase up to 1276 days
Safety-Maintenance Analysis Set included all participants who were administered any dose of the maintenance phase study medication or participants randomized to the chemotherapy arm who are designated to receive BSC only. Participants included in the treatment arm according to study treatment actually 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 | Chemotherapy + Best Supportive Care (BSC) | Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m^2 or 400 mg/m^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance Phase, participants continued the same regimen of oxaliplatin-fluoropyrimidine doublet chemotherapy (oxaliplatin + 5FU/Leucovorin (LV) or oxaliplatin + capecitabine) as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. Participants who were not deemed eligible to receive chemotherapy at the dose and schedule specified above received BSC alone once every 3 weeks. BSC was defined as treatment administered with the intent to maximize quality of life without a specific antineoplastic regimen and was based on Investigator's discretion. | 13 | 238 | 75 | 238 | 203 | 238 |
| EG001 | Avelumab | Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m^2 or 400 mg/m^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity or discontinuation. | 16 | 243 | 89 | 243 | 191 | 243 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Gastric stenosis | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Oesophageal carcinoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Prinzmetal angina | Cardiac disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Thrombotic microangiopathy | Blood and lymphatic system disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Anastomotic stenosis | Injury, poisoning and procedural complications | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Anastomotic ulcer haemorrhage | Injury, poisoning and procedural complications | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Chemical burn of respiratory tract | Injury, poisoning and procedural complications | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Gastrostomy tube site complication | Injury, poisoning and procedural complications | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Contrast media reaction | Immune system disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Nephrostomy | Surgical and medical procedures | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA version 22.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 22.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 22.0 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@emdgroup.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 23, 2019 | Sep 30, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000609138 | avelumab |
| D000077150 | Oxaliplatin |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Native Hawaiian or other Pacific Islander |
|
| Not collected at this site |
|
| Other |
|
| Missing |
|
| OG001 | Avelumab | Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m^2 or 400 mg/m^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity or discontinuation. |
|
|
|
| OG001 | Avelumab | Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m^2 or 400 mg/m^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity or discontinuation. |
|
|
| OG001 | Avelumab | Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m^2 or 400 mg/m^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity or discontinuation. |
|
|
|
| OG001 | Avelumab | Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m^2 or 400 mg/m^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity or discontinuation. |
|
|
| OG001 | Avelumab | Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m^2 or 400 mg/m^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity or discontinuation. |
|
|
| OG001 | Avelumab | Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m^2 or 400 mg/m^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity or discontinuation. |
|
|
Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m^2 or 400 mg/m^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance Phase, participants continued the same regimen of oxaliplatin-fluoropyrimidine doublet chemotherapy (oxaliplatin + 5FU/Leucovorin (LV) or oxaliplatin + capecitabine) as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation. Participants who were not deemed eligible to receive chemotherapy at the dose and schedule specified above received BSC alone once every 3 weeks. BSC was defined as treatment administered with the intent to maximize quality of life without a specific antineoplastic regimen and was based on Investigator's discretion.
| OG001 | Avelumab | Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m^2 or 400 mg/m^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity or discontinuation. |
|
|
| OG001 | Avelumab | Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m^2 or 400 mg/m^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity or discontinuation. |
|
|
| OG001 | Avelumab | Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m^2 or 400 mg/m^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity or discontinuation. |
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| OG001 | Avelumab | Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m^2 or 400 mg/m^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity or discontinuation. |
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| OG001 | Avelumab | Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m^2 or 400 mg/m^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity or discontinuation. |
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| OG001 | Avelumab | Oxaliplatin was administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin at a dose of 200 mg/m^2 or 400 mg/m^2 on Day 1 followed by 5-Fluorouracil at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 or at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Day 1 and 2) every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks for up to 12 weeks in Induction phase. In Maintenance phase, participants received avelumab as a 1-hour intravenous (IV) infusion at 10 milligrams per kilogram (mg/kg) once every 2-week treatment cycle until progressive disease or unacceptable toxicity or discontinuation. |
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