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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002423-19 | EudraCT Number | ||
| CTR20170882 | Registry Identifier | ChinaDrugTrials | |
| JapicCTI-194569 | Registry Identifier | Japic | |
| RATIONALE-301 | Other Identifier | BeiGene |
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This Phase 3 study was a global, multicenter trial that randomly assigned participants to either tislelizumab or sorafenib as a first-line treatment for adults with advanced liver cancer (hepatocellular carcinoma) that could not be surgically removed. Before enrolling Japanese participants in the main Phase 3 study, a preliminary assessment of safety and tolerability (the Safety Run-In Sub-study) was conducted in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety Run-In Sub-study | Experimental | Japanese participants received 200 mg intravenous tislelizumab every 3 weeks to assess preliminary safety and tolerability. |
|
| Arm A: Tislelizumab | Experimental | Participants received 200 mg of intravenous tislelizumab every 3 weeks until intolerable toxicity, withdrawal of consent, or the investigator determined no further benefit from the therapy. |
|
| Arm B: Sorafenib | Active Comparator | Participants received 400 mg of oral sorafenib twice daily until intolerable toxicity, consent withdrawal, or the investigator deemed no further benefit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | Tislelizumab 200 mg intravenously (IV) once every three weeks (Q3W) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Run-in Sub-study: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) is any unfavorable or unintended sign (e.g., abnormal lab result), symptom, or disease temporally associated with study drug use, regardless of causality. A serious adverse event (SAE) is defined as any adverse event that:
| From the first dose to 30 days after the last dose, new anticancer therapy, or the analysis cutoff of December 14th, 2023 (a maximum of 64 months) |
| Safety Run-in Sub-study: Serum Concentration of Tislelizumab | Serum concentration of tislelizumab was a pre-specified primary endpoint for the sub-study only. | Cycle 1 and Cycle 5 at end of infusion, 24 hand 72 hours post-dose, and 8 days and 15 days post-dose (each cycle was 3 weeks). |
| Main Study: Overall Survival (OS) | Defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using Kaplan-Meier methodology. Overall survival was a pre-specified primary endpoint for the main study only. | Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) as Assessed by Blinded Independent Review Committee (BIRC) | Defined as the percentage of participants who had partial response or complete response as determined by Blinded Independent Review Committee (BIRC) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in all randomized participants with measurable disease at baseline. ORR was not assessed by the BIRC for participants in the sub-study, and this was not a pre-specified sub-study endpoint. |
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Safety Run-In Sub-study Eligibility Criteria: The study included adult Japanese participants (≥ 20 years) with histologically confirmed hepatocellular carcinoma (HCC) at Barcelona Clinic Liver Cancer (BCLC) Stage C or B. Eligible participants had either received, were ineligible for, or declined standard treatment. Additional requirements were a Child-Pugh A classification within 7 days before enrollment, at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and an Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤ 1.
Main Study Key Inclusion Criteria:
Main Study Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director, MD | BeiGene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Medical Foundation | Fullerton | California | 92835 | United States | ||
| UCLA Hematologyoncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30969136 | Result | Qin S, Finn RS, Kudo M, Meyer T, Vogel A, Ducreux M, Macarulla TM, Tomasello G, Boisserie F, Hou J, Li X, Song J, Zhu AX. RATIONALE 301 study: tislelizumab versus sorafenib as first-line treatment for unresectable hepatocellular carcinoma. Future Oncol. 2019 Jun;15(16):1811-1822. doi: 10.2217/fon-2019-0097. Epub 2019 Apr 10. | |
| 37796513 |
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The main study had 4 phases: Screening, Treatment, Safety Follow-up (up to 30 days post-treatment or 90 days post-tislelizumab for immune events); and Survival Follow-up (duration varied). Randomization in the main study was stratified by macrovascular invasion (present vs absent), extrahepatic spread (present vs absent), etiology (hepatitis C virus vs other), Eastern Cooperative Oncology Group Performance Status (0 vs 1) and geography (Asia [excluding Japan] vs Japan vs Rest of World).
The main study enrolled participants across centers in Asia, Europe, and the U.S. The first participant consented on December 18, 2017, and the study concluded on December 14, 2023. In Japan, a safety run-in sub-study was conducted to evaluate tislelizumab's safety and tolerability in Japanese patients with hepatocellular carcinoma (HCC). Sub-study participants were not assessed for the same primary and secondary endpoints specified for the main study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Safety Run-In Sub-study | Japanese participants received 200 mg intravenous tislelizumab every 3 weeks to assess preliminary safety and tolerability. |
| FG001 | Arm A: Tislelizumab |
| 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 | May 11, 2020 | Dec 6, 2024 |
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| Sorafenib | Drug | Sorafenib 400 mg orally (PO) twice daily (BID) |
|
|
| Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months) |
| Overall Response Rate (ORR) as Assessed by the Investigator | Defined as the percentage of participants who had partial response or complete response as determined by the investigator per RECIST v1.1 in all randomized participants with measurable disease at baseline. | Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months) |
| Progression Free Survival (PFS) as Assessed by BIRC | Defined as the time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurred first, as assessed by the BIRC per RECIST v1.1. Kaplan-Meier methodology was used to estimate the median PFS. PFS was not assessed by the BIRC for participants in the sub-study, and this was not a pre-specified sub-study endpoint. | Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months) |
| Progression Free Survival (PFS) Assessed by the Investigator | Defined as the time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurred first, as assessed by the investigator per RECIST v1.1. Kaplan-Meier methodology was used to estimate the median PFS. | Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months) |
| Duration of Response (DOR) as Assessed by BIRC | Defined as the time from the first occurrence of a documented objective response until the first documentation of progression or death from any cause, whichever occurred first, as determined by the BIRC per RECIST v1.1. Median DOR was estimated using Kaplan-Meier methodology. DOR was not assessed by the BIRC for participants in the sub-study, and this was not a pre-specified sub-study endpoint. | Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months) |
| Duration of Response (DOR) Assessed by the Investigator | Defined as the time from the first occurrence of a documented objective response until the first documentation of progression or death from any cause, whichever occurred first, as assessed by the investigator per RECIST v1.1. Median DOR was estimated using Kaplan-Meier methodology. | Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months) |
| Time to Progression (TTP) Assessed by BIRC | Defined as the time from the date of randomization to the date of the first objectively documented tumor progression as assessed by the BIRC per RECIST v1.1. Median TTP was estimated using Kaplan-Meier methodology. TTP was not assessed by the BIRC for participants in the sub-study, and this was not a pre-specified sub-study endpoint. | Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months) |
| Time to Progression (TTP) as Assessed by the Investigator | Defined as the time from the date of randomization to the date of the first objectively documented tumor progression as assessed by the investigator per RECIST v1.1. Median TTP was estimated using Kaplan-Meier methodology. TTP was not a pre-specified sub-study endpoint. | Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months) |
| Safety Run-in Sub-study: Overall Survival | Defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using Kaplan-Meier methodology. | Up a to 64 months |
| Disease Control Rate (DCR) as Assessed by BIRC | Defined as the percentage of participants whose best overall response (BOR) was complete response, partial response, or stable disease as assessed by the BIRC per RECIST v1.1. DCR was not a pre-specified endpoint for participants in the sub-study. | Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months) |
| Disease Control Rate (DCR) as Assessed by the Investigator | Defined as the percentage of participants whose best overall response (BOR) was complete response, partial response, or stable disease as assessed by the investigator per RECIST v1.1. DCR was not a pre-specified endpoint for participants in the sub-study. | Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months) |
| Clinical Benefit Rate (CBR) as Assessed by BIRC | Defined as the percentage of participants whose best overall response (BOR) was complete response, partial response, or stable disease greater than or equal to 24 weeks in duration, as assessed by the BIRC per RECIST v1.1. CBR was not a pre-specified endpoint for participants in the sub-study. | Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months) |
| Clinical Benefit Rate (CBR) as Assessed by the Investigator | Defined as the percentage of participants whose best overall response (BOR) is complete response, partial response, or stable disease greater than or equal to 24 weeks in duration, as assessed by the investigator per RECIST v1.1. CBR was not a pre-specified endpoint for participants in the sub-study. | Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months) |
| Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Hepatocellular Carcinoma 18 Questions (EORTC QLQ HCC 18) Index Score at Cycle 4 | The EORTC QLQ-HCC18 is a questionnaire specifically designed to assess health-related quality of life in participants with hepatocellular carcinoma. It includes six symptom scales measuring Fatigue (3 items), Jaundice (2 items), Body Image (2 items), Nutrition (5 items), Pain (2 items), Fever (2 items) and two single items measuring Sex Life and Abdominal Swelling. Participants respond on a scale from 1 = "Not at all" to 4 = "Very Much. Raw scores are transformed into a 0 to 100 scale using linear transformation. The HCC18 Index score is calculated from each of the 6 symptom scales and the 2 single items, and ranges from 0 to 100. Higher scores indicate greater symptom burden or worse quality of life. The EORTC QLQ-HCC18 was not assessed for participants in the sub-study. | Baseline to Cycle 4 (each cycle was 21 days) |
| Change From Baseline in the European EORTC QLQ HCC 18 Index Score at Cycle 6 | The EORTC QLQ-HCC18 is a questionnaire specifically designed to assess health-related quality of life in participants with hepatocellular carcinoma. It includes six symptom scales measuring Fatigue (3 items), Jaundice (2 items), Body Image (2 items), Nutrition (5 items), Pain (2 items), Fever (2 items) and two single items measuring Sex Life and Abdominal Swelling. Participants respond on a scale from 1 = "Not at all" to 4 = "Very Much. Raw scores are transformed into a 0 to 100 scale using linear transformation. The HCC18 Index score is calculated from each of the 6 symptom scales and the 2 single items, and ranges from 0 to 100. Higher scores indicate greater symptom burden or worse quality of life. The HEORTC QLQ-HCC18 was not assessed in participants in the sub-study. | Baseline to Cycle 6 (Each cycle was 21 days) |
| Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life Score at Cycle 4 | The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of participants with cancer. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes. The EORTC QLQ-C30 was not assessed in participants in the sub-study. | Baseline to Cycle 4 (each cycle was 21 days) |
| Change From Baseline in the EORTC QLQ-C30 Global Health Status/Quality of Life Score at Cycle 6 | The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of participants with cancer. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes. The EORTC QLQ-C30 was not assessed in participants in the sub-study. | Baseline to Cycle 6 (each cycle was 21 days) |
| Change From Baseline in the European Quality of Life 5 Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS) at Cycle 4 | The EQ-5D-5L comprises a descriptive module and a Visual Analogue scale (VAS). The EQ-5D-5L VAS measures respondent's self-rated health status on a 0 to 100 scale, with 100 = 'the best health you can imagine' and 0 = 'the worst health you can imagine'. Higher scores on VAS indicate higher health status. The EQ-5D-5L VAS was not assessed in participants in the sub-study. | Baseline to Cycle 4 (each cycle was 21 days) |
| Change From Baseline in the EQ-5D-5L VAS at Cycle 6 | The EQ-5D-5L comprises a descriptive module and a visual analogue scale (VAS). The EQ-5D-5L VAS measures respondent's self-rated health status on a 0 to 100 scale, with 100 = 'the best health you can imagine' and 0 = 'the worst health you can imagine'. Higher scores on VAS indicate higher health status. The EQ-5D-5L VAS was not assessed in participants in the sub-study. | Baseline to Cycle 6 (each cycle was 21 days) |
| Main Study: Number of Participants With Treatment-emergent Adverse Events | An adverse event (AE) is any unfavorable or unintended sign (e.g., abnormal lab result), symptom, or disease temporally associated with study drug use, regardless of causality. A serious adverse event (SAE) is defined as any adverse event that:
| From the first dose to 30 days after the last dose, new anticancer therapy, or the study completion analysis cutoff on December 14th, 2023 (a maximum of 61 months for participants in Arm A and 63 months for participants in Arm B). |
| Safety Run-in Sub-study: Number of Participants Who Developed Anti-tislelizumab Antibodies | Treatment-emergent anti-drug antibodies (ADA): participants who were ADA negative at baseline and ADA positive post-baseline. Treatment-boosted ADA: participants who were ADA positive at baseline that was boosted to a 4-fold or higher-level following drug administration. ADA assessments were not performed for participants enrolled in the main study. | From the first dose to 30 days after the last dose, new anticancer therapy, or the analysis cutoff of December 14th, 2023 (a maximum of 64 months) |
| Los Angeles |
| California |
| 90095 |
| United States |
| Chao Family Comprehensive Cancer Center | Orange | California | 92868 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Umdnj Njms | Newark | New Jersey | 07840 | United States |
| Rj Zuckerberg Cancer Center | Lake Success | New York | 11042 | United States |
| Xcancerdayton Physician Network | Dayton | Ohio | 45409 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Ut Health San Antonio Mays Cancer Center | San Antonio | Texas | 78229 | United States |
| The First Affiliated Hospital of Bengbu Medical College | Bengbu | Anhui | 233004 | China |
| Anhui Provincial Hospital | Hefei | Anhui | 230000 | China |
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230000 | China |
| The Second Hospital of Anhui Medical University | Hefei | Anhui | 230601 | China |
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China |
| Military Hospital of China | Beijing | Beijing Municipality | 100039 | China |
| Beijing Youan Hospital, Capital Medical University | Beijing | Beijing Municipality | 100069 | 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 |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 630014 | China |
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350001 | China |
| Fujian Cancer Hospital | Fuzhou | Fujian | 350014 | China |
| Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North) | Guangzhou | Guangdong | 510000 | China |
| Guangdong Provincial Peoples Hospital | Guangzhou | Guangdong | 510080 | China |
| The First Affiliated Hospital, Sun Yat Sen University | Guangzhou | Guangdong | 510080 | China |
| Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | 510515 | China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150000 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450000 | China |
| Union Hospital of Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
| Zhongnan Hospital of Wuhan University Wuhan | Wuhan | Hubei | 430071 | China |
| Hubei Cancer Hospital | Wuhan | Hubei | 430079 | China |
| General Hospital of Eastern Theater Command | Nanjing | Jiangsu | 210002 | China |
| Jiangsu Province Cancer Hospital | Nanjing | Jiangsu | 210008 | China |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
| Jilin Province Peoples Hospital | Changchun | Jilin | 130021 | China |
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| The First Affiliated Hospital of Xian Jiaotong University | Xi'an | Shaanxi | 710061 | China |
| The Affiliated Hospital of Qingdao University Branch Laoshan | Qingdao | Shandong | 266000 | China |
| Weifang Peoples Hospital | Weifang | Shandong | 261000 | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200000 | China |
| Affiliated Zhongshan Hospital of Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310003 | China |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310016 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| Fakultni Nemocnice Brno | Brno | 62500 | Czechia |
| Fakultni Nemocnice V Motole | Prague | 150 06 | Czechia |
| Chu Caen Normandie | Caen | 14033 | France |
| Hopital Beaujon | Clichy | 92210 | France |
| Chu Besancon Hopital Jean Minjoz | Doubs | 25030 | France |
| Chu de Grenoble Oncology | Grenoble | 38043 | France |
| Chru de Lille Hopital Claude Huriez Hepato Gastro Enterologie | Lille | 59037 | France |
| Chu Montpellier Hopital Saint Eloi | Montpellier | 34295 | France |
| Centre Hospitalier Universitaire Nantes Hotel Dieu | Nantes | 44093 | France |
| Hopital Larchet Chu Nice | Nice | 6200 | France |
| Chu de Poitiers Site de La Mileterie | Poitiers | 86000 | France |
| Hopital Robert Debre | Reims | 51056 | France |
| Chu Saint Etienne Hopital Nord | Saint-Priest-en-Jarez | 42270 | France |
| Hopital Paul Brousse Aphp | Villejuif | 94800 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Charite Universitatsmedizin Berlin | Berlin | 13353 | Germany |
| Universitatsklinikum Bonn | Bonn | 53127 | Germany |
| Uniklinik Koln (Aor) | Cologne | 50937 | Germany |
| Universitatsklinikum Dusseldorf | Düsseldorf | 40225 | Germany |
| Kliniken Essen Mitte Evang Huyssens Stiftung | Essen | 45136 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Universitaetsklinikum Leipzig Aor | Leipzig | 04103 | Germany |
| Policlinico Sorsola Malpighi, Aou Di Bologna | Bologna | 40138 | Italy |
| Po Di Cremona, Asst Di Cremona Oncologia Medica | Cremona | 26100 | Italy |
| Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco | Modena | 41124 | Italy |
| Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi | Pavia | 27100 | Italy |
| Ulssdolomiti | Peschiera del Garda | 37019 | Italy |
| Po Umberto I, Ao Ordine Mauriziano | Torino | 10128 | Italy |
| Osp Sbortolo, Ulss Berica | Vicenza | 36100 | Italy |
| Fujita Health University Hospital | Toyoake | Aichi-ken | 470-1192 | Japan |
| Ehime Prefectural Central Hospital Gastroenterologic Medicine | Matsuyama | Ehime | 790-0024 | Japan |
| National Hospital Organization Kyushu Medical Center | Fukuokacity | Fukuoka | 810-8563 | Japan |
| Ogaki Municipal Hospital Gastroenterological Medicine | Ōgaki | Gifu | 503-8502 | Japan |
| Hokkaido University Hospital | Sapporo | Hokkaido | 060-8648 | Japan |
| Hyogo Medical University Hospital | Nishinomiyashi | Hyōgo | 663-8501 | Japan |
| Kanazawa University Hospital | Kanazawa | Ishikawa-ken | 920-8641 | Japan |
| Iwate Medical University Hospital | Yahabacho Shiwagun | Iwate | 028-3695 | Japan |
| Yokohama City University Medical Center Gastroenterological Center | Yokohama | Kanagawa | 232-0024 | Japan |
| Kanagawa Cancer Center | Yokohama | Kanagawa | 241-8515 | Japan |
| National Hospital Organization Nagasaki Medical Center Gastroenterology | Ōmura | Nagasaki | 856-8562 | Japan |
| Nho Osaka National Hospital | Osakashi | Osaka | 540-0006 | Japan |
| Osaka International Cancer Institute | Osakashi | Osaka | 541-8567 | Japan |
| Kindai University Hospital | Sayama | Osaka | 589-8511 | Japan |
| Osaka University Hospital | Suitashi | Osaka | 565-0871 | Japan |
| Sasaki Foundation Kyoundo Hospital Hepatology | Bunkyoku | Tokyo | 1138655 | Japan |
| Nihon University Itabashi Hospital Gastroenterological Surgery | Itabashiku | Tokyo | 173-8610 | Japan |
| Japanese Red Cross Medical Center Gastroenterology | Shibuyaku | Tokyo | 150-8935 | Japan |
| Center Hospital of the National Center For Global Health and Medicine | Shinjukuku | Tokyo | 162-8655 | Japan |
| Wakayama Medical University | Wakayama | Wakayama | 641-8510 | Japan |
| Chiba University Hospital Gastroenterological Medicine | Chiba | 260-8677 | Japan |
| Kumamoto University Hospital | Kumamoto | 860-8556 | Japan |
| University Hospital, Kyoto Prefectural Univ of Medicine | Kyoto | 602-8566 | Japan |
| Osaka City General Hospital | Osaka | 534-0021 | Japan |
| Osaka Metropolitan University Hospital | Osaka | 545-8586 | Japan |
| Tottori University Hospital Multidisciplinary Internal Medicine | Tottori | 683-8504 | Japan |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80-952 | Poland |
| Clinical Research Center Sp Z Oo, Medic R Sp K | Poznan | 60-569 | Poland |
| Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy | Warsaw | 02-034 | Poland |
| Centrum Badan Klinicznych | Wroclaw | 51-149 | Poland |
| Hospital Universitario Vall Dhebron | Barcelona | 08035 | Spain |
| Institut Catala Doncologia | Barcelona | 08908 | Spain |
| Hospital Universitario Hm Madrid Sanchinarro | Madrid | 28050 | Spain |
| Hospital Universitari I Politecnic La Fe | Valencia | 46026 | Spain |
| Kaohsiung Medical University Chung Ho Memorial Hospital | Kaohsiung City | 807 | Taiwan |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | 83301 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| Taichung Veterans General Hospital Gastroenterology | Taichung | 407 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
| Chi Mei Medical Center | Tainan | 710 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Tri Service General Hospital | Taipei | 114 | Taiwan |
| Linkou Chang Gung Memorial Hospital | Taoyuan | 33305 | Taiwan |
| Queen Elizabeth Hospital | Birmingham | B15 2TH | United Kingdom |
| The Christie Hospital | Greater Manchester | M20 4BX | United Kingdom |
| Royal Free Hospital London Nhs Trust | London | NW3 2QG | United Kingdom |
| Kings College | London | SE5 9RS | United Kingdom |
| Qin S, Kudo M, Meyer T, Bai Y, Guo Y, Meng Z, Satoh T, Marino D, Assenat E, Li S, Chen Y, Boisserie F, Abdrashitov R, Finn RS, Vogel A, Zhu AX. Tislelizumab vs Sorafenib as First-Line Treatment for Unresectable Hepatocellular Carcinoma: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2023 Dec 1;9(12):1651-1659. doi: 10.1001/jamaoncol.2023.4003. |
| 39435268 | Result | Finn RS, Kudo M, Barnes G, Meyer T, Boisserie F, Abdrashitov R, Chen Y, Li S, Zhu AX, Qin S, Vogel A. Tislelizumab versus Sorafenib in First-Line Treatment of Unresectable Hepatocellular Carcinoma: Impact on Health-Related Quality of Life in RATIONALE-301 Study. Liver Cancer. 2024 Feb 21;13(5):548-560. doi: 10.1159/000537966. eCollection 2024 Oct. |
Participants received 200 mg of intravenous tislelizumab every 3 weeks until intolerable toxicity, withdrawal of consent, or the investigator determined no further benefit from the therapy.
| FG002 | Arm B: Sorafenib | Participants received 400 mg of oral sorafenib twice daily until intolerable toxicity, consent withdrawal, or the investigator deemed no further benefit. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Sub-study: Safety Analysis Set includes all participants in the safety run-in sub-study who received at least one dose of any study drug.
Main Study: Intent-to-Treat Analysis Set includes all participants randomized in the main study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Safety Run-In Sub-study | Japanese participants received 200 mg intravenous tislelizumab every 3 weeks to assess preliminary safety and tolerability. |
| BG001 | Arm A: Tislelizumab | Participants received 200 mg of intravenous tislelizumab every 3 weeks until intolerable toxicity, withdrawal of consent, or the investigator determined no further benefit from the therapy. |
| BG002 | Arm B: Sorafenib | Participants received 400 mg of oral sorafenib twice daily until intolerable toxicity, consent withdrawal, or the investigator deemed no further benefit. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | The ECOG scale assesses disease status from 0 to 5. A score of 0 means fully active with no restrictions, while 1 indicates limitations in strenuous activities but the ability to do light work. Score 2 signifies ambulatory and capable of self-care, yet unable to work, being active for over 50% of waking hours. Score 3 reflects limited self-care, confined to bed or a chair for more than half the day. Score 4 indicates complete disability, with the participant fully bedbound, and score 5 means deceased. | Count of Participants | Participants |
| |||||||||||||||
| Macrovascular Invasion | Macrovascular invasion refers to the spread of cancer into large blood vessels near the tumor, and is associated with a more advanced stage of disease and a poorer prognosis. When present, cancer has infiltrated major blood vessels; when absent, no invasion into these vessels is detected, indicating a less aggressive disease. | Count of Participants | Participants |
| |||||||||||||||
| Extrahepatic Spread | Extrahepatic spread refers to the spread of liver cancer beyond the liver to other organs or tissues. When present, cancer has metastasized outside the liver; when absent, the cancer is confined to the liver. | Count of Participants | Participants |
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| Geographic Region | Number | participants |
| ||||||||||||||||
| Etiology | Participants were grouped based on the presence of Hepatitis C virus or another virus, with those having both Hepatitis B and C classified under the "other" category. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety Run-in Sub-study: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) is any unfavorable or unintended sign (e.g., abnormal lab result), symptom, or disease temporally associated with study drug use, regardless of causality. A serious adverse event (SAE) is defined as any adverse event that:
| The Sub-study Safety Analysis Set includes all participants in the safety run-in sub-study who received at least one dose of any study drug. | Posted | Count of Participants | Participants | From the first dose to 30 days after the last dose, new anticancer therapy, or the analysis cutoff of December 14th, 2023 (a maximum of 64 months) |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Safety Run-in Sub-study: Serum Concentration of Tislelizumab | Serum concentration of tislelizumab was a pre-specified primary endpoint for the sub-study only. | The Sub-study Pharmacokinetic (PK) Analysis Set includes all participants in the safety run-in sub-study who received at least 1 dose of tislelizumab per the protocol, for whom any post-dose PK data were available at each time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Cycle 1 and Cycle 5 at end of infusion, 24 hand 72 hours post-dose, and 8 days and 15 days post-dose (each cycle was 3 weeks). |
|
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| Primary | Main Study: Overall Survival (OS) | Defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using Kaplan-Meier methodology. Overall survival was a pre-specified primary endpoint for the main study only. | The Intent-To-Treat (ITT) analysis set included all randomized participants in the main study. | Posted | Median | 95% Confidence Interval | Months | Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months) |
|
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| Secondary | Overall Response Rate (ORR) as Assessed by Blinded Independent Review Committee (BIRC) | Defined as the percentage of participants who had partial response or complete response as determined by Blinded Independent Review Committee (BIRC) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in all randomized participants with measurable disease at baseline. ORR was not assessed by the BIRC for participants in the sub-study, and this was not a pre-specified sub-study endpoint. | ITT Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months) |
|
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| Secondary | Overall Response Rate (ORR) as Assessed by the Investigator | Defined as the percentage of participants who had partial response or complete response as determined by the investigator per RECIST v1.1 in all randomized participants with measurable disease at baseline. | Sub-study Safety Analysis Set; Main study ITT Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) as Assessed by BIRC | Defined as the time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurred first, as assessed by the BIRC per RECIST v1.1. Kaplan-Meier methodology was used to estimate the median PFS. PFS was not assessed by the BIRC for participants in the sub-study, and this was not a pre-specified sub-study endpoint. | ITT Analysis Set | Posted | Median | 95% Confidence Interval | months | Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) Assessed by the Investigator | Defined as the time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurred first, as assessed by the investigator per RECIST v1.1. Kaplan-Meier methodology was used to estimate the median PFS. | Sub-study Safety Analysis Set; Main study ITT Analysis Set | Posted | Median | 95% Confidence Interval | Months | Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) as Assessed by BIRC | Defined as the time from the first occurrence of a documented objective response until the first documentation of progression or death from any cause, whichever occurred first, as determined by the BIRC per RECIST v1.1. Median DOR was estimated using Kaplan-Meier methodology. DOR was not assessed by the BIRC for participants in the sub-study, and this was not a pre-specified sub-study endpoint. | ITT Analysis Set. Only participants with best overall response of complete response or partial response confirmed per RECIST v1.1 were included in the analysis, and percentages were based on the number of responders. | Posted | Median | 95% Confidence Interval | months | Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) Assessed by the Investigator | Defined as the time from the first occurrence of a documented objective response until the first documentation of progression or death from any cause, whichever occurred first, as assessed by the investigator per RECIST v1.1. Median DOR was estimated using Kaplan-Meier methodology. | Sub-study Safety Analysis Set; Main study ITT Analysis Set; Only participants with best overall response of complete response or partial response per investigator assessment were included in the analysis. | Posted | Median | 95% Confidence Interval | Months | Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression (TTP) Assessed by BIRC | Defined as the time from the date of randomization to the date of the first objectively documented tumor progression as assessed by the BIRC per RECIST v1.1. Median TTP was estimated using Kaplan-Meier methodology. TTP was not assessed by the BIRC for participants in the sub-study, and this was not a pre-specified sub-study endpoint. | ITT Analysis Set | Posted | Median | 95% Confidence Interval | Months | Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Time to Progression (TTP) as Assessed by the Investigator | Defined as the time from the date of randomization to the date of the first objectively documented tumor progression as assessed by the investigator per RECIST v1.1. Median TTP was estimated using Kaplan-Meier methodology. TTP was not a pre-specified sub-study endpoint. | ITT Analysis Set | Posted | Median | 95% Confidence Interval | months | Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Safety Run-in Sub-study: Overall Survival | Defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using Kaplan-Meier methodology. | Sub-study Safety Analysis Set | Posted | Median | 95% Confidence Interval | months | Up a to 64 months |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) as Assessed by BIRC | Defined as the percentage of participants whose best overall response (BOR) was complete response, partial response, or stable disease as assessed by the BIRC per RECIST v1.1. DCR was not a pre-specified endpoint for participants in the sub-study. | ITT Analysis Set | Posted | Number | percentage of participants | Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months) |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) as Assessed by the Investigator | Defined as the percentage of participants whose best overall response (BOR) was complete response, partial response, or stable disease as assessed by the investigator per RECIST v1.1. DCR was not a pre-specified endpoint for participants in the sub-study. | ITT Analysis Set | Posted | Number | percentage of participants | Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months) |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Clinical Benefit Rate (CBR) as Assessed by BIRC | Defined as the percentage of participants whose best overall response (BOR) was complete response, partial response, or stable disease greater than or equal to 24 weeks in duration, as assessed by the BIRC per RECIST v1.1. CBR was not a pre-specified endpoint for participants in the sub-study. | ITT Analysis Set | Posted | Number | percentage of participants | Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months) |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Clinical Benefit Rate (CBR) as Assessed by the Investigator | Defined as the percentage of participants whose best overall response (BOR) is complete response, partial response, or stable disease greater than or equal to 24 weeks in duration, as assessed by the investigator per RECIST v1.1. CBR was not a pre-specified endpoint for participants in the sub-study. | ITT Analysis Set | Posted | Number | percentage of participants | Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months) |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Hepatocellular Carcinoma 18 Questions (EORTC QLQ HCC 18) Index Score at Cycle 4 | The EORTC QLQ-HCC18 is a questionnaire specifically designed to assess health-related quality of life in participants with hepatocellular carcinoma. It includes six symptom scales measuring Fatigue (3 items), Jaundice (2 items), Body Image (2 items), Nutrition (5 items), Pain (2 items), Fever (2 items) and two single items measuring Sex Life and Abdominal Swelling. Participants respond on a scale from 1 = "Not at all" to 4 = "Very Much. Raw scores are transformed into a 0 to 100 scale using linear transformation. The HCC18 Index score is calculated from each of the 6 symptom scales and the 2 single items, and ranges from 0 to 100. Higher scores indicate greater symptom burden or worse quality of life. The EORTC QLQ-HCC18 was not assessed for participants in the sub-study. | ITT Analysis Set. Only participants with data at both Baseline and Cycle 4 are included | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline to Cycle 4 (each cycle was 21 days) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the European EORTC QLQ HCC 18 Index Score at Cycle 6 | The EORTC QLQ-HCC18 is a questionnaire specifically designed to assess health-related quality of life in participants with hepatocellular carcinoma. It includes six symptom scales measuring Fatigue (3 items), Jaundice (2 items), Body Image (2 items), Nutrition (5 items), Pain (2 items), Fever (2 items) and two single items measuring Sex Life and Abdominal Swelling. Participants respond on a scale from 1 = "Not at all" to 4 = "Very Much. Raw scores are transformed into a 0 to 100 scale using linear transformation. The HCC18 Index score is calculated from each of the 6 symptom scales and the 2 single items, and ranges from 0 to 100. Higher scores indicate greater symptom burden or worse quality of life. The HEORTC QLQ-HCC18 was not assessed in participants in the sub-study. | ITT Analysis Set. Only participants with data at both baseline and Cycle 6 are included | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline to Cycle 6 (Each cycle was 21 days) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life Score at Cycle 4 | The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of participants with cancer. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes. The EORTC QLQ-C30 was not assessed in participants in the sub-study. | ITT Analysis Set. Only participants with data at both Baseline and Cycle 4 are included. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline to Cycle 4 (each cycle was 21 days) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the EORTC QLQ-C30 Global Health Status/Quality of Life Score at Cycle 6 | The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of participants with cancer. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes. The EORTC QLQ-C30 was not assessed in participants in the sub-study. | ITT Analysis Set. Only participants with data at both Baseline and Cycle 6 are included. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline to Cycle 6 (each cycle was 21 days) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the European Quality of Life 5 Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS) at Cycle 4 | The EQ-5D-5L comprises a descriptive module and a Visual Analogue scale (VAS). The EQ-5D-5L VAS measures respondent's self-rated health status on a 0 to 100 scale, with 100 = 'the best health you can imagine' and 0 = 'the worst health you can imagine'. Higher scores on VAS indicate higher health status. The EQ-5D-5L VAS was not assessed in participants in the sub-study. | ITT Analysis Set. Only participants with data at both Baseline and Cycle 4 are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Cycle 4 (each cycle was 21 days) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the EQ-5D-5L VAS at Cycle 6 | The EQ-5D-5L comprises a descriptive module and a visual analogue scale (VAS). The EQ-5D-5L VAS measures respondent's self-rated health status on a 0 to 100 scale, with 100 = 'the best health you can imagine' and 0 = 'the worst health you can imagine'. Higher scores on VAS indicate higher health status. The EQ-5D-5L VAS was not assessed in participants in the sub-study. | ITT Analysis Set. Only participants with data at both Baseline and Cycle 6 are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Cycle 6 (each cycle was 21 days) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Main Study: Number of Participants With Treatment-emergent Adverse Events | An adverse event (AE) is any unfavorable or unintended sign (e.g., abnormal lab result), symptom, or disease temporally associated with study drug use, regardless of causality. A serious adverse event (SAE) is defined as any adverse event that:
| The Safety Analysis Set includes all randomized participants who received at least one dose of any study drug. | Posted | Count of Participants | Participants | From the first dose to 30 days after the last dose, new anticancer therapy, or the study completion analysis cutoff on December 14th, 2023 (a maximum of 61 months for participants in Arm A and 63 months for participants in Arm B). |
| |||||||||||||||||||||||||||||||||||
| Secondary | Safety Run-in Sub-study: Number of Participants Who Developed Anti-tislelizumab Antibodies | Treatment-emergent anti-drug antibodies (ADA): participants who were ADA negative at baseline and ADA positive post-baseline. Treatment-boosted ADA: participants who were ADA positive at baseline that was boosted to a 4-fold or higher-level following drug administration. ADA assessments were not performed for participants enrolled in the main study. | The Sub-study Antidrug antibody (ADA) Analysis Set includes all participants enrolled in the sub-study who received at least one dose of tislelizumab for whom both baseline ADA and at least one postbaseline ADA results were available. | Posted | Count of Participants | Participants | From the first dose to 30 days after the last dose, new anticancer therapy, or the analysis cutoff of December 14th, 2023 (a maximum of 64 months) |
|
|
All-cause mortality is reported from informed consent signing to first dose or discontinuation (Screening Period, 28 days) / from first dose to study completion (sub-study, Arm A and Arm B), up to approximately 65 months. AEs are reported from informed consent signing (SAEs only, in the Screening Period; 28 days) / from first dose of study drug to 30 days after last dose, new anticancer therapy, or study completion (up to 64 months in the sub-study, 61 months in Arm A, and 63 months in Arm B).
Results for the sub-study, Arm A, and Arm B are reported for all participants who received treatment (Safety Analysis Set). The Screening Period group includes all enrolled participants, including those who did not receive any study treatment.
Other (non-serious) adverse events were not collected during the screening period or for participants who did not receive 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 | Safety Run-In Sub-study | Japanese participants received 200 mg intravenous tislelizumab every 3 weeks to assess preliminary safety and tolerability. | 7 | 10 | 1 | 10 | 8 | 10 |
| EG001 | Arm A: Tislelizumab | Participants received 200 mg of intravenous tislelizumab every 3 weeks until intolerable toxicity, withdrawal of consent, or the investigator determined no further benefit from the therapy. | 258 | 338 | 104 | 338 | 313 | 338 |
| EG002 | Arm B: Sorafenib | Participants received 400 mg of oral sorafenib twice daily until intolerable toxicity, consent withdrawal, or the investigator deemed no further benefit. | 273 | 324 | 91 | 324 | 318 | 324 |
| EG003 | Screening Period: All Enrolled Participants | All enrolled participants. This group includes deaths and serious adverse events collected from the date of signing the informed consent form and prior to first dose of study drug for participants who received study drug or until study discontinuation for participants who discontinued the study without receiving any study drug. | 1 | 684 | 7 | 684 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold type haemolytic anaemia | Blood and lymphatic system disorders | meddra 24 | Systematic Assessment |
| |
| Hypersplenism | Blood and lymphatic system disorders | meddra 24 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | meddra 24 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | meddra 24 | Systematic Assessment |
| |
| Microvascular coronary artery disease | Cardiac disorders | meddra 24 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | meddra 24 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | meddra 24 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | meddra 24 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | meddra 24 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | meddra 24 | Systematic Assessment |
| |
| Cataract | Eye disorders | meddra 24 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | meddra 24 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | meddra 24 | Systematic Assessment |
| |
| Anorectal varices | Gastrointestinal disorders | meddra 24 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | meddra 24 | Systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | meddra 24 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | meddra 24 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | meddra 24 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | meddra 24 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | meddra 24 | Systematic Assessment |
| |
| Haemoperitoneum | Gastrointestinal disorders | meddra 24 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | meddra 24 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | meddra 24 | Systematic Assessment |
| |
| Intra-abdominal fluid collection | Gastrointestinal disorders | meddra 24 | Systematic Assessment |
| |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | meddra 24 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | meddra 24 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | meddra 24 | Systematic Assessment |
| |
| Varices oesophageal | Gastrointestinal disorders | meddra 24 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | meddra 24 | Systematic Assessment |
| |
| Death | General disorders | meddra 24 | Systematic Assessment |
| |
| Fatigue | General disorders | meddra 24 | Systematic Assessment |
| |
| Gait disturbance | General disorders | meddra 24 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | meddra 24 | Systematic Assessment |
| |
| Malaise | General disorders | meddra 24 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | meddra 24 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | meddra 24 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | meddra 24 | Systematic Assessment |
| |
| Pyrexia | General disorders | meddra 24 | Systematic Assessment |
| |
| Acute hepatic failure | Hepatobiliary disorders | meddra 24 | Systematic Assessment |
| |
| Biliary obstruction | Hepatobiliary disorders | meddra 24 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | meddra 24 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | meddra 24 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | meddra 24 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | meddra 24 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | meddra 24 | Systematic Assessment |
| |
| Hepatic haemorrhage | Hepatobiliary disorders | meddra 24 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | meddra 24 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | meddra 24 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | meddra 24 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | meddra 24 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | meddra 24 | Systematic Assessment |
| |
| Jaundice hepatocellular | Hepatobiliary disorders | meddra 24 | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | meddra 24 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | meddra 24 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | meddra 24 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | meddra 24 | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | meddra 24 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | meddra 24 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | meddra 24 | Systematic Assessment |
| |
| Colonic abscess | Infections and infestations | meddra 24 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | meddra 24 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | meddra 24 | Systematic Assessment |
| |
| Infection | Infections and infestations | meddra 24 | Systematic Assessment |
| |
| Influenza | Infections and infestations | meddra 24 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | meddra 24 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | meddra 24 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | meddra 24 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | meddra 24 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | meddra 24 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | meddra 24 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | meddra 24 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | meddra 24 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | meddra 24 | Systematic Assessment |
| |
| Varicella | Infections and infestations | meddra 24 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | meddra 24 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | meddra 24 | Systematic Assessment |
| |
| Extradural haematoma | Injury, poisoning and procedural complications | meddra 24 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | meddra 24 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | meddra 24 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | meddra 24 | Systematic Assessment |
| |
| Hepatic rupture | Injury, poisoning and procedural complications | meddra 24 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | meddra 24 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | meddra 24 | Systematic Assessment |
| |
| Radiation oesophagitis | Injury, poisoning and procedural complications | meddra 24 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | meddra 24 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | meddra 24 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | meddra 24 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | meddra 24 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | meddra 24 | Systematic Assessment |
| |
| Hepatic enzyme abnormal | Investigations | meddra 24 | Systematic Assessment |
| |
| Transaminases increased | Investigations | meddra 24 | Systematic Assessment |
| |
| Weight decreased | Investigations | meddra 24 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | meddra 24 | Systematic Assessment |
| |
| Hyperamylasaemia | Metabolism and nutrition disorders | meddra 24 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | meddra 24 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | meddra 24 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | meddra 24 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | meddra 24 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | meddra 24 | Systematic Assessment |
| |
| Osteolysis | Musculoskeletal and connective tissue disorders | meddra 24 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | meddra 24 | Systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | meddra 24 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | meddra 24 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24 | Systematic Assessment |
| |
| Intraductal papillary mucinous neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24 | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24 | Systematic Assessment |
| |
| Liver carcinoma ruptured | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24 | Systematic Assessment |
| |
| Oesophageal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24 | Systematic Assessment |
| |
| Tumour rupture | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | meddra 24 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | meddra 24 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | meddra 24 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | meddra 24 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | meddra 24 | Systematic Assessment |
| |
| Hemiplegia | Nervous system disorders | meddra 24 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | meddra 24 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | meddra 24 | Systematic Assessment |
| |
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | meddra 24 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | meddra 24 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | meddra 24 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | meddra 24 | Systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | meddra 24 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | meddra 24 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | meddra 24 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | meddra 24 | Systematic Assessment |
| |
| Pelvic fluid collection | Reproductive system and breast disorders | meddra 24 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | meddra 24 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | meddra 24 | Systematic Assessment |
| |
| Hepatopulmonary syndrome | Respiratory, thoracic and mediastinal disorders | meddra 24 | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | meddra 24 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | meddra 24 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | meddra 24 | Systematic Assessment |
| |
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | meddra 24 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | meddra 24 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | meddra 24 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | meddra 24 | Systematic Assessment |
| |
| Acute generalised exanthematous pustulosis | Skin and subcutaneous tissue disorders | meddra 24 | Systematic Assessment |
| |
| Immune-mediated dermatitis | Skin and subcutaneous tissue disorders | meddra 24 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | meddra 24 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | meddra 24 | Systematic Assessment |
| |
| Radiotherapy | Surgical and medical procedures | meddra 24 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | meddra 24 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | meddra 24 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | meddra 24 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | meddra 24 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | meddra 24 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | meddra 24 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | meddra 24 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | meddra 24 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | meddra 24 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | meddra 24 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | meddra 24 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | meddra 24 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | meddra 24 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | meddra 24 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | meddra 24 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | meddra 24 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | meddra 24 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | meddra 24 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | meddra 24 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | meddra 24 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | meddra 24 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | meddra 24 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | meddra 24 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | meddra 24 | Systematic Assessment |
| |
| Asthenia | General disorders | meddra 24 | Systematic Assessment |
| |
| Fatigue | General disorders | meddra 24 | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | meddra 24 | Systematic Assessment |
| |
| Malaise | General disorders | meddra 24 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | meddra 24 | Systematic Assessment |
| |
| Pyrexia | General disorders | meddra 24 | Systematic Assessment |
| |
| Hepatic pain | Hepatobiliary disorders | meddra 24 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | meddra 24 | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | meddra 24 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | meddra 24 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | meddra 24 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | meddra 24 | Systematic Assessment |
| |
| Influenza | Infections and infestations | meddra 24 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | meddra 24 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | meddra 24 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | meddra 24 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | meddra 24 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | meddra 24 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | meddra 24 | Systematic Assessment |
| |
| Post procedural fever | Injury, poisoning and procedural complications | meddra 24 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | meddra 24 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | meddra 24 | Systematic Assessment |
| |
| Amylase increased | Investigations | meddra 24 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | meddra 24 | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | meddra 24 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | meddra 24 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | meddra 24 | Systematic Assessment |
| |
| Blood bilirubin unconjugated increased | Investigations | meddra 24 | Systematic Assessment |
| |
| Blood creatine phosphokinase MB increased | Investigations | meddra 24 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | meddra 24 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | meddra 24 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | meddra 24 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | meddra 24 | Systematic Assessment |
| |
| Hepatitis C RNA increased | Investigations | meddra 24 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | meddra 24 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | meddra 24 | Systematic Assessment |
| |
| Weight decreased | Investigations | meddra 24 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | meddra 24 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | meddra 24 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | meddra 24 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | meddra 24 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | meddra 24 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | meddra 24 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | meddra 24 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | meddra 24 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | meddra 24 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | meddra 24 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | meddra 24 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | meddra 24 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | meddra 24 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | meddra 24 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | meddra 24 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | meddra 24 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | meddra 24 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | meddra 24 | Systematic Assessment |
| |
| Headache | Nervous system disorders | meddra 24 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | meddra 24 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | meddra 24 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | meddra 24 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | meddra 24 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | meddra 24 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | meddra 24 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | meddra 24 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | meddra 24 | Systematic Assessment |
| |
| Pulmonary artery thrombosis | Respiratory, thoracic and mediastinal disorders | meddra 24 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | meddra 24 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | meddra 24 | Systematic Assessment |
| |
| Dermatitis psoriasiform | Skin and subcutaneous tissue disorders | meddra 24 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | meddra 24 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | meddra 24 | Systematic Assessment |
| |
| Neurodermatitis | Skin and subcutaneous tissue disorders | meddra 24 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | meddra 24 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | meddra 24 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | meddra 24 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | meddra 24 | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | meddra 24 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | meddra 24 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | meddra 24 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | meddra 24 | 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 | 1-877-828-5568 | clinicaltrials@beigene.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: SAP for Primary Analysis CSR | Apr 21, 2022 | Dec 6, 2024 | SAP_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: SAP for Study Closeout Analysis CSR | Dec 22, 2023 | Dec 6, 2024 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| Male |
|
| White |
|
| Not Reported |
|
| Unknown |
|
| Black or African American |
|
| American Indian or Alaska Native |
|
| Native Hawaiian or Other Pacific Islander |
|
| Other |
|
| 1 (Restricted but ambulatory) |
|
| Absent |
|
| Absent |
|
| Japan |
|
| European Union (EU)/United States (US) |
|
| Other |
|
|
|
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