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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000312-24 | EudraCT Number | ||
| CTR20181841 | Registry Identifier | ChinaDrugTrials | |
| JapicCTI-194799 | Registry Identifier | Japic |
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This study was designed to compare the efficacy and safety of tislelizumab plus chemotherapy versus placebo plus chemotherapy as the first treatment (first-line) for adults diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tislelizumab + Chemotherapy | Experimental | Participants received 200 mg of tislelizumab intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Chemotherapy consisted of 1000 mg/m² capecitabine twice daily on Days 1-14 and 130 mg/m² oxaliplatin on Day 1, or 800 mg/m² 5-fluorouracil (5-FU) on Days 1-5 and 80 mg/m² cisplatin on Day 1 of each 21-day cycle. Thereafter, participants continued treatment with 200 mg tislelizumab, with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity. |
|
| Placebo + Chemotherapy | Placebo Comparator | Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Chemotherapy consisted of 1000 mg/m² capecitabine twice daily on Days 1-14 and 130 mg/m² oxaliplatin on Day 1, or 800 mg/m² 5-FU on Days 1-5 and 80 mg/m² cisplatin on Day 1 of each 21-day cycle. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | 200 mg intravenously (IV) on Day 1 of each 21-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival in PD-L1 Positive Participants | Overall survival (OS) is defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method. | From randomization up to the primary analysis data cut-off date of 8 October 2021; Median (range) time on follow-up was 11.8 (0.1 - 33.4) months. |
| Overall Survival in the Intent-to-Treat (ITT) Analysis Set | Overall survival (OS) is defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method. | From randomization up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) in PD-L1 Positive Participants | Progression-free survival is defined as the time from the date of randomization to the date of the first objectively documented tumor progression assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Jin Wang, MD | BeiGene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis Health System | Sacramento | California | 95817 | United States | ||
| Southeastern Regional Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42371751 | Derived | Rha SY, Ryu MH, Kim JG, Xu S, Xu Y, Lee KW. Comparative efficacy of tislelizumab + FOLFOX or CAPOX for gastric/gastroesophageal junction adenocarcinoma: an exploratory matching-adjusted indirect comparison. Curr Med Res Opin. 2026 Jun 29:1-11. doi: 10.1080/03007995.2026.2686048. Online ahead of print. | |
| 42262249 | Derived |
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Participants were randomly assigned to either tislelizumab plus investigator chosen chemotherapy (ICC) or placebo plus ICC.
Randomization was stratified according to region (China [including Taiwan] vs Japan and South Korea vs Europe/North America), programmed cell death protein ligand-1 (PD-L1) expression (PDL1 tumor area positivity (TAP) score ≥5% or <5%), peritoneal metastases (yes vs no), and investigator's choice of chemotherapy (capecitabine + oxaliplatin, or 5-fluorouracil + cisplatin).
This study was conducted at 141 study centers in 13 countries across Asia, Europe, and North America. Adults with histologically confirmed, locally advanced unresectable or metastatic gastric or gastrooesophageal junction adenocarcinoma and no previous systemic therapy for advanced disease were recruited.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tislelizumab + Chemotherapy | Participants received 200 mg of tislelizumab intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Chemotherapy consisted of 1000 mg/m² capecitabine twice daily on Days 1-14 and 130 mg/m² oxaliplatin on Day 1, or 800 mg/m² 5-fluorouracil (5-FU) on Days 1-5 and 80 mg/m² cisplatin on Day 1 of each 21-day cycle. Thereafter, participants continued treatment with 200 mg tislelizumab, with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity. |
| 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 | Apr 17, 2023 | Jan 24, 2025 |
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| Placebo | Drug | Placebo to match tislelizumab IV on Day 1 of each 21-day cycle |
|
| Cisplatin | Drug | 80 mg/m² IV on Day 1 of each 21-day cycle |
|
| Oxaliplatin | Drug | 130 mg/m² IV on Day 1 of each 21-day cycle |
|
| Capecitabine | Drug | 1000 mg/m² orally twice daily (BD) Days 1 through 14 (14 days total) of each 21-day cycle |
|
| 5-Fluorouracil | Drug | 800 mg/m²/day IV using continuous infusion on Days 1 to 5 of each 21-day cycle |
|
| From randomization up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. |
| Overall Response Rate (ORR) in PD-L1 Positive Participants | ORR is defined as the percentage of participants whose best overall response is complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors v1.1 assessed by the investigator. Investigators conducted assessments of radiological tumor response by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST version 1.1 about every six weeks during the first 48 weeks of the study and every nine weeks thereafter. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, persistence of one or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits. | Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. |
| Progression-free Survival (PFS) in the ITT Analysis Set | Progression-free survival is defined as the time from the date of randomization to the date of the first objectively documented tumor progression assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. | From randomization up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. |
| Overall Response Rate (ORR) in the ITT Analysis Set | ORR is defined as the percentage of participants whose best overall response is complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors v1.1 assessed by the investigator. Investigators conducted assessments of radiological tumor response by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST version 1.1 about every six weeks during the first 48 weeks of the study and every nine weeks thereafter. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, persistence of one or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits. | Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. |
| Duration of Response (DOR) in PD-L1 Positive Participants | DOR is defined as the time from the first determination of an objective response assessed by the investigator per RECIST v1.1, until the first documentation of progression or death, whichever occurred first. Progressive disease (PD): At least a 20% increase in the size of target lesions, taking as reference the smallest size on study, with an absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or any new lesions. | Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. |
| Duration of Response in the ITT Analysis Set | DOR is defined as the time from the first determination of an objective response assessed by the investigator per RECIST v1.1, until the first documentation of progression or death, whichever occurred first. Progressive disease (PD): At least a 20% increase in the size of target lesions, taking as reference the smallest size on study, with an absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or any new lesions. | Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. |
| Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL) and Physical Functioning Scores | The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed to a 0 to 100 scale via linear transformation. Higher scores in GHS and functional scales indicate better quality of life. | Baseline and Cycles 4 and 6 |
| Change From Baseline in EORTC QLQ-C30 Fatigue Score | The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed to a 0 to 100 scale via linear transformation. The fatigue symptom scale includes 3 items and ranges from 0 to 100, where higher scores indicate a higher level of symptoms. | Baseline and Cycles 4 and 6 |
| Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Gastric Cancer Module QLQ-STO22 (EORTC QLQ-STO22) | EORTC-QLQ-STO22 is a 22-item questionnaire developed to assess QoL of gastric cancer participants. It consists of 5 multi-item subscales: Dysphagia/odynophagia (4 items), Pain/discomfort (3 items), Dietary restrictions (5 items), Upper gastro-intestinal (GI) symptoms (3 items), Specific emotional problems (3 items) and 4 single items. Each question is answered on a scale from 0 (Not at all) to 4 (Very Much), where lower scores indicate fewer symptoms/better QoL. Raw scores were transformed to a scale from 0 to 100, where lower scores indicate better QoL. The QLQ-STO22 Index score is the mean of the 6 domain scores and 4 single items. | Baseline and Cycles 4 and 6 |
| Change From Baseline in European Quality of Life 5-Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS) | The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes. | Baseline and Cycles 4 and 6 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drugs, whether related to study drugs or not. An SAE is any untoward medical occurrence that, at any dose met any of the following criteria:
| From first dose of study drug to 30 days after last dose or the initiation of a new anticancer therapy, whichever occurred first, up to the end of study; maximum treatment duration was 59.3 months in Tislelizumab and 56.8 months in the Placebo group. |
| Disease Control Rate in PD-L1 Positive Participants | Disease Control Rate is defined as the percentage of participants who had confirmed CR, PR, or stable disease (SD) assessed by the investigator and the investigator per RECIST v1.1. Investigators conducted assessments of radiological tumor response by CT or MRI per RECIST version 1.1 about every six weeks during the first 48 weeks of the study and every nine weeks thereafter. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, persistence of one or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: Neither sufficient shrinkage in size of lesions to qualify for PR nor sufficient increase to qualify for PD, and no new lesions. | Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. |
| Disease Control Rate in the ITT Analysis Set | Disease Control Rate is defined as the percentage of participants who had confirmed CR, PR, or stable disease (SD) assessed by the investigator per RECIST v1.1. Investigators conducted assessments of radiological tumor response by CT or MRI per RECIST version 1.1 about every six weeks during the first 48 weeks of the study and every nine weeks thereafter. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, persistence of one or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: Neither sufficient shrinkage in size of lesions to qualify for PR nor sufficient increase to qualify for PD, and no new lesions. | Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. |
| Clinical Benefit Rate (CBR) in PD-L1 Positive Participants | Clinical benefit rate is defined as the percentage of participants who achieved a confirmed complete response, partial response, or durable stable disease assessed by the Investigator per RECIST v1.1. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, persistence of one or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits. Durable SD: Stable disease for ≥ 24 weeks. | Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. |
| Clinical Benefit Rate (CBR) in the ITT Analysis Set | Clinical benefit rate is defined as the percentage of participants who achieved a confirmed complete response, partial response, or durable stable disease assessed by the Investigator per RECIST v1.1. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, persistence of one or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits. Durable SD: Stable disease for ≥ 24 weeks. | Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. |
| Time to Response (TTR) in PD-L1 Positive Participants | Time to response is defined as the time from randomization to the first determination of an objective response per RECIST version 1.1 as assessed by the investigator. | From randomization up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. |
| Time to Response (TTR) in the ITT Analysis Set | Time to response is defined as the time from randomization to the first determination of an objective response per RECIST version 1.1 as assessed by the investigator. | From randomization up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. |
| Newnan |
| Georgia |
| 30265 |
| United States |
| Ohio State University Hospital | Columbus | Ohio | 43210 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Reading Hospital | West Reading | Pennsylvania | 19611 | United States |
| Tennessee Oncology, Pllc Nashville | Nashville | Tennessee | 37203 | United States |
| The First Affiliated Hospital of Bengbu Medical College | Bengbu | Anhui | 233004 | China |
| Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital | Hefei | Anhui | 230088 | China |
| The Second Hospital of Anhui Medical University | Hefei | Anhui | 230601 | China |
| Peking University Third Hospital | Beijing | Beijing Municipality | 100000 | China |
| Beijing Chao Yang Hospital | Beijing | Beijing Municipality | 100020 | China |
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China |
| Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing Municipality | 100050 | China |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
| Chinese Pla General Hospital | Beijing | Beijing Municipality | 100853 | China |
| Beijing Luhe Hospital, Capital Medical University | Beijing | Beijing Municipality | 101149 | China |
| Daping Hospital, Third Military Medical University | Chongqing | Chongqing Municipality | 400042 | China |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | 350005 | China |
| Fujian Cancer Hospital | Fuzhou | Fujian | 350014 | China |
| The First Hospital of Lanzhou University | Lanzhou | Gansu | 730000 | China |
| Foshan First Peoples Hospital | Foshan | Guangdong | 528000 | China |
| Sun Yat Sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| Guangdong Provincial Peoples Hospital | Guangzhou | Guangdong | 510080 | China |
| Shenzhen Peoples Hospital | Shenzhen | Guangdong | 518020 | China |
| Affiliated Hospital of Guilin Medical University | Guilin | Guangxi | 541001 | China |
| Hainan General Hospital | Haikou | Hainan | 570206 | China |
| The Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050011 | China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150000 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450000 | China |
| Henan Provincial Peoples Hospital | Zhengzhou | Henan | 450003 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| Union Hospital of Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
| Hubei Cancer Hospital | Wuhan | Hubei | 430079 | China |
| Xiangya Hospital of Central South University | Changsha | Hunan | 410008 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
| Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School | Nanjing | Jiangsu | 210008 | China |
| Nantong Tumor Hospital Branch South | Nantong | Jiangsu | 226000 | China |
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| The First Hospital of China Medical University | Shenyang | Liaoning | 110001 | China |
| The General Hospital of Shenyang Military | Shenyang | Liaoning | 110016 | China |
| Liaoning Cancer Hospital and Institute | Shenyang | Liaoning | 110042 | China |
| Shandong Cancer Hospital | Jinan | Shandong | 250117 | China |
| Linyi Cancer Hospital | Linyi | Shandong | 276001 | China |
| The Affiliated Hospital of Qingdao University Branch South | Qingdao | Shandong | 266000 | China |
| Rui Jin Hospital Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
| Affiliated Zhongshan Hospital of Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| Shanghai General Hospital | Shanghai | Shanghai Municipality | 200080 | China |
| Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200092 | China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| Yunnan Cancer Hospital | Kunming | Yunnan | 650100 | China |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310003 | China |
| Zhejiang University College of Medicine Second Affiliated Hospital | Hangzhou | Zhejiang | 310009 | China |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310016 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| Centre Georges Francois Leclerc | Dijon | 21079 | France |
| Chu Besancon Hopital Jean Minjoz | Doubs | 25030 | France |
| Hopital de La Timone | Marseille | 13005 | France |
| Icl Alexis Vautrin | Meurthe Et Moselle | 54519 | France |
| Hopital Nord Franche Comte Site Du Mittan | Montbéliard | 25200 | France |
| Centre Antoine Lacassagne | Nice | 06100 | France |
| Chu Bordeaux Hopital Haut Leveque | Pessac | 33600 | France |
| Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi | Bologna | 40138 | Italy |
| Fondazione Irccs Istituto Nazionale Dei Tumori | Milan | 20133 | Italy |
| Istituto Nazionale Tumori Fondazione G Pascale | Naples | 80131 | Italy |
| Iov Istituto Oncologico Veneto Irccs | Padova | 35128 | Italy |
| Ao Ospedali Riuniti Marche Nord | Pesaro | 61122 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | 56126 | Italy |
| Azienda Ospedaliera Universitaria Policlinico Tor Vergata | Roma | 133 | Italy |
| Irccs Ospedale Casa Sollievo Della Sofferenza | San Giovanni Rotondo | 71013 | Italy |
| Aou Senese Policlinico Santa Maria Alle Scotte | Siena | 53100 | Italy |
| Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino | Torino | 10126 | Italy |
| Azienda Ospedaliera Universitaria Delle Marche | Torrette | 60020 | Italy |
| Chiba Cancer Center | Chiba | Chiba | 260-8717 | Japan |
| Tesshokai Kameda General Hospital | Kamogawashi | Chiba | 296-8602 | Japan |
| Nho Shikoku Cancer Center | Matsuyama | Ehime | 791-0280 | Japan |
| Nho Kyushu Cancer Center | Fukuoka | Fukuoka | 811-1395 | Japan |
| Gunma Prefectural Cancer Center | Otashi | Gunma | 373-8550 | Japan |
| Hokkaido University Hospital | Sapporo | Hokkaido | 060-8648 | Japan |
| Johas Kansai Rosai Hospital | Amagasakishi | Hyōgo | 660-8511 | Japan |
| Ishikawa Prefectural Central Hospital | Kanazawa | Ishikawa-ken | 920-8530 | Japan |
| Kagawa University Hospital | Kitagun | Kagawa-ken | 761-0793 | Japan |
| Kanagawa Cancer Center | Yokohama | Kanagawa | 241-8515 | Japan |
| Oita University Hospital | Yufushi | Oita Prefecture | 879-5593 | Japan |
| Kurashiki Central Hospital | Kurashikishi | Okayama-ken | 710-8602 | Japan |
| Okayama University Hospital | Okayama | Okayama-ken | 700-8558 | Japan |
| Izumi City General Hospital | Izumishi | Osaka | 594-0073 | Japan |
| Nho Osaka National Hospital | Osakashi | Osaka | 540-0006 | Japan |
| Osaka University Hospital | Suitashi | Osaka | 565-0871 | Japan |
| Saitama Medical University International Medical Center | Hidakashi | Saitama | 350-1298 | Japan |
| Saitama Cancer Center | Kitaadachigun | Saitama | 362-0806 | Japan |
| Hamamatsu University School of Medicine, University Hospital | Hamamatsushi | Shizuoka | 431-3192 | Japan |
| National Cancer Center Hospital | Chuoku | Tokyo | 104-0045 | Japan |
| Tokyo Metropolitan Tama Medical Center | Fuchushi | Tokyo | 183-8524 | Japan |
| Cancer Institute Hospital of Jfcr | Kotoku | Tokyo | 135-8550 | Japan |
| Center Hospital of the National Center For Global Health and Medicine | Shinjukuku | Tokyo | 162-8655 | Japan |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80-952 | Poland |
| Centrum Terapii Wspolczesnej Jm Jasnorzewska Sp Komandytowo Akcyjna | Lodz | 90-242 | Poland |
| Przychodnia Med Polonia Sp Z Oo | Poznan | 60-693 | Poland |
| Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy | Warsaw | 02-034 | Poland |
| Pan American Oncology Trials, Llc | Rio Piedras | 00935 | Puerto Rico |
| Arkhangelsk Regional Clinical Oncological Dispensary | Arkhangelsk | Arkhangelskaya oblast | 163045 | Russia |
| Rbih Ivanovo Regional Oncological Dispensary | Ivanovo | Ivanovo Oblast | 153040 | Russia |
| Vitamed Llc | Moscow | Moscow | 121309 | Russia |
| Sbhi of Novosibirsk Region Novosibirsk Regional Oncological Dispensary | Novosibirsk | Novosibirsk Oblast | 630108 | Russia |
| Bih of Omsk Region Clinical Oncology Dispensary | Omsk | Omsk Oblast | 644013 | Russia |
| Private Educational Institution of Higher Education Medical University Reaviz | Samara | Samaraskaya Oblast' | 443011 | Russia |
| Pavlov First Saint Petersburg State Medical University | SaintPetersburg | Sankt-Peterburg | 197022 | Russia |
| Fsbi Clinical Research and Practical Center For Specialized Medical Care (Oncology) | SanktPetersburg | Sankt-Peterburg | 197758 | Russia |
| State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary | Volgograd | Volgograd Oblast | 400138 | Russia |
| Sbih of Yaroslavl Region Regional Clinical Oncological Hospital | Yaroslavl | Yaroslavl Oblast | 150054 | Russia |
| National Cancer Center | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| The Catholic University of Korea, St Vincents Hospital | Suwon | Gyeonggi-do | 16247 | South Korea |
| Ajou University Hospital | Suwon | Gyeonggi-do | 16499 | South Korea |
| Kyungpook National University Chilgok Hospital | Daegu | Gyeongsangbukdo | 41404 | South Korea |
| Chonnam National University Hwasun Hospital | HwasunGun | Jeollanam-do | 58128 | South Korea |
| Seoul National University Hospital | Seoul | Seoul Teugbyeolsi | 03080 | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | Seoul Teugbyeolsi | 03722 | South Korea |
| Asan Medical Center | Seoul | Seoul Teugbyeolsi | 05505 | South Korea |
| Chung Ang University Hospital | Seoul | Seoul Teugbyeolsi | 6973 | South Korea |
| Hospital Clinic de Barcelona | Barcelona | 8036 | Spain |
| Hospital de Basurto | Bilbao | 48013 | Spain |
| Hospital General Universitario de Elche | Elche | 3203 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28007 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitario Hm Madrid Sanchinarro | Madrid | 28050 | Spain |
| Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | 28222 | Spain |
| Hospital Regional Universitario de Malaga | Málaga | 29010 | Spain |
| Complejo Hospitalario de Navarra | Pamplona | 31008 | Spain |
| Hospital Universitario Virgen Del Rocio | Seville | 41013 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Initia Oncologia, Slp | Valencia | 46010 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| Kaohsiung Medical University Chung Ho Memorial Hospital | Kaohsiung City | 807 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Acibadem Adana Hospital | Adana | 01130 | Turkey (Türkiye) |
| Dr Abdurrahman Yurtaslan Oncology Teaching and Research Hospital | Ankara | 06620 | Turkey (Türkiye) |
| Nonu Universitesi Tip Fakultesi | Battalgazi | 44280 | Turkey (Türkiye) |
| Dicle University Medical Faculty | Diyarbakır | 21080 | Turkey (Türkiye) |
| Akdeniz University Hospital | Konyaalt | 07070 | Turkey (Türkiye) |
| Iu C, Clinical Research Excellence Application and Research Center | Stanbul | 34098 | Turkey (Türkiye) |
| Namik Kemal University | Tekirdağ | 59100 | Turkey (Türkiye) |
| Karadeniz Tecnical Uni Med Fac | Trabzon | 61080 | Turkey (Türkiye) |
| Velindre Cancer Centre | Cardiff | CF14 2TL | United Kingdom |
| Sarah Cannon Research Institute Uk | London | W1G 6AD | United Kingdom |
| Kato K, Xu RH, Oh DY, Bai Y, Shi J, Lee KW, Hirano H, Xu H, Sheng T, B Barnes F, Barnes G. Tislelizumab plus chemotherapy vs placebo plus chemotherapy as first-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma: patient-reported outcomes in the Asian subgroup of the RATIONALE-305 study. Curr Med Res Opin. 2026 Apr;42(4):809-819. doi: 10.1080/03007995.2026.2682010. Epub 2026 Jun 9. |
| 42205142 | Derived | Qiu MZ, Lee KW, Mohler M, Luo HY, Hirano H, Zhang T, Wang FH, Ba Y, Rha SY, Wang F, He MM, Xu S, Pan X, Xu RH. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment in patients with advanced gastric or gastroesophageal junction adenocarcinoma, with or without peritoneal metastases: a post-hoc analysis on RATIONALE-305 study. EClinicalMedicine. 2026 May 15;95:103980. doi: 10.1016/j.eclinm.2026.103980. eCollection 2026 May. |
| 41251890 | Derived | Cruz-Correa M, Oh DY, Kato K, Tabernero J, Bai Y, Shi J, Lee KW, Hirano H, Spigel D, Wyrwicz L, Pazo Cid R, Cubillo Gracian A, Xu Y, Sheng T, Yang S, Xu RH, Moehler M. Tislelizumab + Chemotherapy in Gastric Cancer: Long-Term RATIONALE-305 Randomized Trial Follow-up. Adv Ther. 2026 Jan;43(1):165-183. doi: 10.1007/s12325-025-03415-0. Epub 2025 Nov 18. |
| 40528576 | Derived | Cruz-Correa M, Xu RH, Moehler M, Oh DY, Kato K, Spigel D, Arkenau HT, Tabernero J, Zimina AV, Bai Y, Shi J, Lee KW, Hirano H, Wyrwicz L, Cid RP, Xu H, Sheng T, Barnes G. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma: patient-reported outcomes in the RATIONALE-305 study. Curr Med Res Opin. 2025 Jun;41(6):1007-1016. doi: 10.1080/03007995.2025.2501588. Epub 2025 Jun 18. |
| 40075025 | Derived | Moehler M, Oh DY, Kato K, Arkenau T, Tabernero J, Lee KW, Rha SY, Hirano H, Spigel D, Yamaguchi K, Wyrwicz L, Disel U, Pazo-Cid RA, Fornaro L, Xu Y, Sheng T, Yang S, Kadva A, Cruz-Correa M, Xu RH. First-Line Tislelizumab Plus Chemotherapy for Advanced Gastric Cancer with Programmed Death-Ligand 1 Expression >/= 1%: A Retrospective Analysis of RATIONALE-305. Adv Ther. 2025 May;42(5):2248-2268. doi: 10.1007/s12325-025-03133-7. Epub 2025 Mar 13. |
| 38923910 | Derived | Li W, Wan L, Zhang J. Cost-effectiveness of tislelizumab plus chemotherapy vs chemotherapy as first-line treatment of PD-L1 positive advanced gastric or gastroesophageal junction adenocarcinoma from a Chinese perspective. Expert Rev Gastroenterol Hepatol. 2024 Jun;18(6):293-301. doi: 10.1080/17474124.2024.2373730. Epub 2024 Jun 28. |
| 38806195 | Derived | Qiu MZ, Oh DY, Kato K, Arkenau T, Tabernero J, Correa MC, Zimina AV, Bai Y, Shi J, Lee KW, Wang J, Poddubskaya E, Pan H, Rha SY, Zhang R, Hirano H, Spigel D, Yamaguchi K, Chao Y, Wyrwicz L, Disel U, Cid RP, Fornaro L, Evesque L, Wang H, Xu Y, Li J, Sheng T, Yang S, Li L, Moehler M, Xu RH; RATIONALE-305 Investigators. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first line treatment for advanced gastric or gastro-oesophageal junction adenocarcinoma: RATIONALE-305 randomised, double blind, phase 3 trial. BMJ. 2024 May 28;385:e078876. doi: 10.1136/bmj-2023-078876. |
| FG001 | Placebo + Chemotherapy | Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Chemotherapy consisted of 1000 mg/m² capecitabine twice daily on Days 1-14 and 130 mg/m² oxaliplatin on Day 1, or 800 mg/m² 5-FU on Days 1-5 and 80 mg/m² cisplatin on Day 1 of each 21-day cycle. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity. |
| Received Treatment |
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| COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tislelizumab + Chemotherapy | Participants received 200 mg of tislelizumab intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with 200 mg tislelizumab, with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity. |
| BG001 | Placebo + Chemotherapy | Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| 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 |
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| Geographic Region | Count of Participants | Participants |
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| Primary Tumor Location | *One participant in the placebo + chemotherapy arm did not report primary location and disease stage, as the diagnosis of this participant was updated from gastric adenocarcinoma to be pancreatic cancer after randomization. | Count of Participants | Participants |
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| PD-L1 Expression | PDL1 expression was assessed by a central laboratory using the TAP score, defined as total percentage of tumor area (tumor and any desmoplastic stroma) covered by tumor cells with PD-L1 membrane staining (any intensity), and tumor associated immune cells with PD-L1 staining (any intensity), visually estimated by pathologists using an investigational use only version of the Ventana PDL1 (SP263) assay. | Count of Participants | Participants |
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| Presence of Peritoneal Metastasis | Count of Participants | Participants |
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| Investigator Chosen Chemotherapy | 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 | Overall Survival in PD-L1 Positive Participants | Overall survival (OS) is defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method. | The PD-L1-Positive Analysis Set included all randomized participants whose tumors were PD-L1 positive (defined as PD-L1 TAP score ≥ 5%) | Posted | Median | 95% Confidence Interval | months | From randomization up to the primary analysis data cut-off date of 8 October 2021; Median (range) time on follow-up was 11.8 (0.1 - 33.4) months. |
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| Primary | Overall Survival in the Intent-to-Treat (ITT) Analysis Set | Overall survival (OS) is defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method. | The Intent-to-Treat (ITT) Analysis Set included all randomized participants. | Posted | Median | 95% Confidence Interval | months | From randomization up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. |
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| Secondary | Progression-free Survival (PFS) in PD-L1 Positive Participants | Progression-free survival is defined as the time from the date of randomization to the date of the first objectively documented tumor progression assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. | PD-L1 Positive Analysis Set | Posted | Median | 95% Confidence Interval | months | From randomization up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. |
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| Secondary | Overall Response Rate (ORR) in PD-L1 Positive Participants | ORR is defined as the percentage of participants whose best overall response is complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors v1.1 assessed by the investigator. Investigators conducted assessments of radiological tumor response by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST version 1.1 about every six weeks during the first 48 weeks of the study and every nine weeks thereafter. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, persistence of one or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits. | PD-L1 Positive Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. |
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| Secondary | Progression-free Survival (PFS) in the ITT Analysis Set | Progression-free survival is defined as the time from the date of randomization to the date of the first objectively documented tumor progression assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. | Intent-to-Treat Analysis Set | Posted | Median | 95% Confidence Interval | months | From randomization up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. |
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| Secondary | Overall Response Rate (ORR) in the ITT Analysis Set | ORR is defined as the percentage of participants whose best overall response is complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors v1.1 assessed by the investigator. Investigators conducted assessments of radiological tumor response by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST version 1.1 about every six weeks during the first 48 weeks of the study and every nine weeks thereafter. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, persistence of one or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits. | Intent-to-Treat (ITT) Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. |
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| Secondary | Duration of Response (DOR) in PD-L1 Positive Participants | DOR is defined as the time from the first determination of an objective response assessed by the investigator per RECIST v1.1, until the first documentation of progression or death, whichever occurred first. Progressive disease (PD): At least a 20% increase in the size of target lesions, taking as reference the smallest size on study, with an absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or any new lesions. | Participants in the PD-L1 Positive Analysis Set with an objective response | Posted | Median | 95% Confidence Interval | months | Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. |
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| Secondary | Duration of Response in the ITT Analysis Set | DOR is defined as the time from the first determination of an objective response assessed by the investigator per RECIST v1.1, until the first documentation of progression or death, whichever occurred first. Progressive disease (PD): At least a 20% increase in the size of target lesions, taking as reference the smallest size on study, with an absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or any new lesions. | Participants in the ITT Analysis Set with an objective response | Posted | Median | 95% Confidence Interval | months | Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. |
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| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL) and Physical Functioning Scores | The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed to a 0 to 100 scale via linear transformation. Higher scores in GHS and functional scales indicate better quality of life. | Participants in the ITT Analysis Set who completed the EORTC QLQ-C30 at baseline; participants with available data at baseline and the relevant postbaseline visit are included in the analysis at each time point. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline and Cycles 4 and 6 |
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| Secondary | Change From Baseline in EORTC QLQ-C30 Fatigue Score | The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed to a 0 to 100 scale via linear transformation. The fatigue symptom scale includes 3 items and ranges from 0 to 100, where higher scores indicate a higher level of symptoms. | Participants in the ITT Analysis Set who completed the EORTC QLQ-C30 at baseline; participants with available data at baseline and the relevant postbaseline visit are included in the analysis at each time point. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline and Cycles 4 and 6 |
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| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Gastric Cancer Module QLQ-STO22 (EORTC QLQ-STO22) | EORTC-QLQ-STO22 is a 22-item questionnaire developed to assess QoL of gastric cancer participants. It consists of 5 multi-item subscales: Dysphagia/odynophagia (4 items), Pain/discomfort (3 items), Dietary restrictions (5 items), Upper gastro-intestinal (GI) symptoms (3 items), Specific emotional problems (3 items) and 4 single items. Each question is answered on a scale from 0 (Not at all) to 4 (Very Much), where lower scores indicate fewer symptoms/better QoL. Raw scores were transformed to a scale from 0 to 100, where lower scores indicate better QoL. The QLQ-STO22 Index score is the mean of the 6 domain scores and 4 single items. | Participants in the ITT Analysis Set who completed the EORTC QLQ-STO22 at baseline; participants with available data at baseline and the relevant postbaseline visit are included in the analysis at each time point. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline and Cycles 4 and 6 |
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| Secondary | Change From Baseline in European Quality of Life 5-Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS) | The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes. | Participants in the ITT Analysis Set who completed the EQ-5D-5L at baseline; participants with available data at baseline and the relevant postbaseline visit are included in the analysis at each time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Cycles 4 and 6 |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drugs, whether related to study drugs or not. An SAE is any untoward medical occurrence that, at any dose met any of the following criteria:
| The Safety Analysis Set included all participants who received ≥ 1 dose of study drug | Posted | Count of Participants | Participants | From first dose of study drug to 30 days after last dose or the initiation of a new anticancer therapy, whichever occurred first, up to the end of study; maximum treatment duration was 59.3 months in Tislelizumab and 56.8 months in the Placebo group. |
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| Secondary | Disease Control Rate in PD-L1 Positive Participants | Disease Control Rate is defined as the percentage of participants who had confirmed CR, PR, or stable disease (SD) assessed by the investigator and the investigator per RECIST v1.1. Investigators conducted assessments of radiological tumor response by CT or MRI per RECIST version 1.1 about every six weeks during the first 48 weeks of the study and every nine weeks thereafter. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, persistence of one or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: Neither sufficient shrinkage in size of lesions to qualify for PR nor sufficient increase to qualify for PD, and no new lesions. | PD-L1 Positive Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. |
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| Secondary | Disease Control Rate in the ITT Analysis Set | Disease Control Rate is defined as the percentage of participants who had confirmed CR, PR, or stable disease (SD) assessed by the investigator per RECIST v1.1. Investigators conducted assessments of radiological tumor response by CT or MRI per RECIST version 1.1 about every six weeks during the first 48 weeks of the study and every nine weeks thereafter. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, persistence of one or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits. SD: Neither sufficient shrinkage in size of lesions to qualify for PR nor sufficient increase to qualify for PD, and no new lesions. | ITT Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. |
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| Secondary | Clinical Benefit Rate (CBR) in PD-L1 Positive Participants | Clinical benefit rate is defined as the percentage of participants who achieved a confirmed complete response, partial response, or durable stable disease assessed by the Investigator per RECIST v1.1. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, persistence of one or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits. Durable SD: Stable disease for ≥ 24 weeks. | PD-L1 Positive Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. |
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| Secondary | Clinical Benefit Rate (CBR) in the ITT Analysis Set | Clinical benefit rate is defined as the percentage of participants who achieved a confirmed complete response, partial response, or durable stable disease assessed by the Investigator per RECIST v1.1. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, persistence of one or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits. Durable SD: Stable disease for ≥ 24 weeks. | ITT Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. |
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| Secondary | Time to Response (TTR) in PD-L1 Positive Participants | Time to response is defined as the time from randomization to the first determination of an objective response per RECIST version 1.1 as assessed by the investigator. | Participants in the PD-L1 Positive Analysis Set with an objective response | Posted | Median | Full Range | months | From randomization up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. |
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| Secondary | Time to Response (TTR) in the ITT Analysis Set | Time to response is defined as the time from randomization to the first determination of an objective response per RECIST version 1.1 as assessed by the investigator. | Participants in the ITT Analysis Set with an objective response | Posted | Median | Full Range | months | From randomization up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. |
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From first dose of study drug to 30 days after last dose or the initiation of a new anticancer therapy, whichever occurred first, up to the end of study; maximum treatment duration was 59.3 months in Tislelizumab and 56.8 months in the Placebo group.
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment.
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 | Tislelizumab + Chemotherapy | Participants received 200 mg of tislelizumab intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with 200 mg tislelizumab, with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity. | 397 | 501 | 211 | 498 | 489 | 498 |
| EG001 | Placebo + Chemotherapy | Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity. | 431 | 496 | 179 | 494 | 485 | 494 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
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| Disseminated intravascular coagulation | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
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| Immune thrombocytopenia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | 24.0 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | 24.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | 24.0 | Systematic Assessment |
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| Cardiopulmonary failure | Cardiac disorders | 24.0 | Systematic Assessment |
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| Coronary artery occlusion | Cardiac disorders | 24.0 | Systematic Assessment |
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| Left ventricular failure | Cardiac disorders | 24.0 | Systematic Assessment |
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| Myocarditis | Cardiac disorders | 24.0 | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | 24.0 | Systematic Assessment |
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| Pericarditis | Cardiac disorders | 24.0 | Systematic Assessment |
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| Sinus arrest | Cardiac disorders | 24.0 | Systematic Assessment |
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| Hypoacusis | Ear and labyrinth disorders | 24.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | 24.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | 24.0 | Systematic Assessment |
| |
| Cataract subcapsular | Eye disorders | 24.0 | Systematic Assessment |
| |
| Extraocular muscle paresis | Eye disorders | 24.0 | Systematic Assessment |
| |
| Macular fibrosis | Eye disorders | 24.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | 24.0 | Systematic Assessment |
| |
| Abdominal adhesions | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Appendicitis noninfective | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Bezoar | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Gastric perforation | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Gastric stenosis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Gastrointestinal necrosis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Gastrointestinal stenosis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Ischaemic enteritis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Mesenteric panniculitis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Oesophageal food impaction | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Oesophageal obstruction | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Rectal stenosis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Volvulus of small bowel | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 24.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | 24.0 | Systematic Assessment |
| |
| Death | General disorders | 24.0 | Systematic Assessment |
| |
| Device related thrombosis | General disorders | 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 24.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | 24.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | 24.0 | Systematic Assessment |
| |
| Malaise | General disorders | 24.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | 24.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 24.0 | Systematic Assessment |
| |
| Polyserositis | General disorders | 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 24.0 | Systematic Assessment |
| |
| Sudden death | General disorders | 24.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Biliary obstruction | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Gallbladder obstruction | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Venoocclusive liver disease | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | 24.0 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | 24.0 | Systematic Assessment |
| |
| Immune-mediated adverse reaction | Immune system disorders | 24.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | 24.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Complicated appendicitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Brain herniation | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Gastrointestinal anastomotic stenosis | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Heat illness | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Remnant gastritis | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Spinal cord injury | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | 24.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase MB increased | Investigations | 24.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 24.0 | Systematic Assessment |
| |
| Eastern Cooperative Oncology Group performance status worsened | Investigations | 24.0 | Systematic Assessment |
| |
| Fibrin D dimer increased | Investigations | 24.0 | Systematic Assessment |
| |
| Fibrin degradation products increased | Investigations | 24.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 24.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Latent autoimmune diabetes in adults | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Immune-mediated myositis | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Joint adhesion | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Malignant ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Pulmonary tumour thrombotic microangiopathy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| IIIrd nerve paralysis | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Myasthenia gravis | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Paraplegia | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | 24.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 24.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | 24.0 | Systematic Assessment |
| |
| Immune-mediated renal disorder | Renal and urinary disorders | 24.0 | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | 24.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | 24.0 | Systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | 24.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pulmonary infarction | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Aortic thrombosis | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Brachiocephalic vein thrombosis | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Embolism arterial | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | 24.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | 24.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 24.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | 24.0 | Systematic Assessment |
| |
| Chills | General disorders | 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 24.0 | Systematic Assessment |
| |
| Malaise | General disorders | 24.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | 24.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 24.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | 24.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Weight increased | Investigations | 24.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 24.0 | Systematic Assessment |
|
BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information & may request a further delay to protect its IP rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | BeiGene | 877-828-5568 | Clinicaltrials@beigene.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 18, 2021 | Jan 24, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D002945 | Cisplatin |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| White |
|
| Not Reported |
|
| Other |
|
| Unknown |
|
| Japan and South Korea |
|
| North America/Europe |
|
| Gastro-oesophageal junction |
|
| Other* |
|
| ≥ 5% |
|
| No |
|
| Cisplatin + 5-Fluorouracil |
|
| Superiority |
|
|
|
|
|
|
| OG001 | Placebo + Chemotherapy | Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity. |
|
|
|
|
|
|
| OG001 | Placebo + Chemotherapy | Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity. |
|
|
|
|
|
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| OG001 | Placebo + Chemotherapy | Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity. |
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| OG001 | Placebo + Chemotherapy | Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity. |
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| Placebo + Chemotherapy |
Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity. |
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| Placebo + Chemotherapy |
Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity. |
|
|
| OG001 | Placebo + Chemotherapy | Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity. |
|
|
| OG001 | Placebo + Chemotherapy | Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity. |
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|
Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity. |
|
|
Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.
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| Units | Counts |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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