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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20211753 | Other Identifier | ChinaDrugTrials |
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The purpose of this study is to evaluate the pathological complete response (pCR) in participants receiving tislelizumab plus chemotherapy/chemoradiotherapy as neoadjuvant treatment.
This study enrolled participants with esophageal squamous cell carcinoma who were eligible to have their tumor removed by surgery (also called surgical resection). The treatment phase of the study included the following:
Induction therapy, in which participants received 1 cycle of chemotherapy;
Neoadjuvant therapy (neoadjuvant refers to treatment that occurs before surgery, which can make the tumor easier to remove). In this study participants received neoadjuvant therapy based on their response to induction therapy. Response to induction therapy was assessed using the maximum standardized uptake value (SUVmax) measured using a Positron Emission Tomography (PET) scan. The SUV number refers to the level of brightness on the PET scan which reflects metabolic activity; increased metabolic activity can indicate cancerous growth.
Surgery to remove the remaining tumor (resection) was to occur 4-6 weeks after completion of neoadjuvant treatment.
After surgery participants were followed until death, lost to follow-up, withdrawal of consent, or until the study was completed
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A (Responder) | Experimental | Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in positron emission tomography (PET) Standardized Uptake Value (SUV)max ≥ 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and chemotherapy doublet (cisplatin + paclitaxel) for 2 cycles. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later. |
|
| Cohort B (Non-responder) | Experimental | Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in PET SUVmax < 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and investigator-chosen chemotherapy doublet (paclitaxel + cisplatin or 5-fluorouracil + cisplatin) for 2 cycles plus concurrent radiotherapy. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | Administered intravenously on Day 1 of each 21-Day Cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Complete Response (pCR) Rate | The pCR rate was defined as the percentage of participants with absence of residual tumor in the resected primary tumor and all resected lymph nodes after completion of neoadjuvant treatment. pCR rates were assessed by a pathologist at each site. | pCR was determined from samples taken during surgery; surgery occurred 4-6 weeks after the last dose of chemotherapy, approximately Day 71-86 |
| Measure | Description | Time Frame |
|---|---|---|
| R0 Resection Rate | Defined as the percentage of participants with R0 resection. R0 resection refers to a surgical procedure where the entire tumor is completely removed with no evidence of residual cancer tissue at the surgical margins. | Resection was planned to occur 4-6 weeks after the last dose of chemotherapy, approximately Day 71-86 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Ineligible for treatment with any of the chemotherapy doublets of protocol-specified chemotherapy.
Any prior therapy for current ESCC, including investigational agents, chemotherapy, radiotherapy, targeted therapy agents, or prior therapy with an anti-programmed cell death protein-1, anti-programmed cell death protein ligand-1, anti-programmed cell death protein ligand-2, or any other antibody or drug specifically targeting T-Cell co-stimulation or checkpoint pathways.
History of fistula due to primary tumor invasion.
Participants with high risk of fistula or sign of perforation evaluated by investigator.
Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days before first dose.
* Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent) and topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption, and short course (≤ 7 days) of corticosteroid prescribed prophylactically or for the treatment of a non-autoimmune condition are permitted.
Active autoimmune diseases or history of autoimmune diseases that may relapse.
* Controlled Type I diabetes, hypothyroidism only requiring hormone replacement, controlled celiac disease, skin diseases (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases.
With infections requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis infection.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Hefei | Anhui | 230000 | China | ||
| Fujian Medical University Union Hospital |
BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
See plan description
See plan description
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This study was conducted at 8 study centers in China.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A (Responder) | Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in positron emission tomography (PET) Standardized Uptake Value (SUV)max ≥ 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and chemotherapy doublet (cisplatin + paclitaxel) for 2 cycles. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later. |
| FG001 | Cohort B (Non-responder) | Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in PET SUVmax < 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and investigator-chosen chemotherapy doublet (paclitaxel + cisplatin or 5-fluorouracil + cisplatin) for 2 cycles plus concurrent radiotherapy. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A (Responder) | Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in positron emission tomography (PET) Standardized Uptake Value (SUV)max ≥ 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and chemotherapy doublet (cisplatin + paclitaxel) for 2 cycles. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Pathological Complete Response (pCR) Rate | The pCR rate was defined as the percentage of participants with absence of residual tumor in the resected primary tumor and all resected lymph nodes after completion of neoadjuvant treatment. pCR rates were assessed by a pathologist at each site. | The Efficacy Evaluable Analysis Set included all participants who received neoadjuvant treatment followed by surgery. | Posted | Number | 95% Confidence Interval | percentage of participants | pCR was determined from samples taken during surgery; surgery occurred 4-6 weeks after the last dose of chemotherapy, approximately Day 71-86 |
|
All-cause-mortality: From first dose until the end of study; maximum time on study follow-up was 37.3 months. AEs: From the first dose of study drug up to 30 days after the last treatment (any component of combination treatment or surgery, whichever is last) or the initiation of subsequent anticancer therapy, whichever occurred first. Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab, up to approximately 9 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A (Responder) | Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in positron emission tomography (PET) Standardized Uptake Value (SUV)max ≥ 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and chemotherapy doublet (cisplatin + paclitaxel) for 2 cycles. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Granulocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | BeiGene | 1 877-828-5568 | clinicaltrials@beigene.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 22, 2022 | Nov 14, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 26, 2023 | Oct 14, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D017239 | Paclitaxel |
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Paclitaxel | Drug | 135 mg/m^2 administered intravenously on Day 1 of each 21-Day Cycle. |
|
| Cisplatin | Drug | 80 mg/m^2 administered intravenously on Day 1 of each 21-Day Cycle. |
|
| 5-fluorouracil | Drug | 1000 mg/m^2 administered intravenously over Day 1 through 4 of each 21-Day Cycle. |
|
| Radiotherapy | Radiation | 40 grays/20 fractions |
|
| Surgical resection | Procedure | Performed as indicated in the treatment arm. |
|
| 1-year/3-year Disease-free Survival (DFS) Rate |
The DFS rate is defined as the percentage of participants free from disease events at 1 year and 3 years after the first date of no disease (R0 resection as surgery outcome). Disease events include local or distant recurrence or death due to any cause. The DFS rate was analyzed only for participants who underwent R0 resection. Disease-free rates were estimated using the Kaplan-Meier method with 95% confidence intervals estimated using the Greenwood formula. |
| 1 year and 3 years after surgery |
| 1-year/3-year Event-free Survival (EFS) Rate | The EFS rate is defined as the percentage of participants free from EFS events at 1 year and 3 years after the first dose. The EFS events include progression of disease that precludes definitive surgery, local or distant recurrence, or death due to any cause. Event-free rates were estimated using the Kaplan-Meier method with 95% confidence intervals estimated using the Greenwood formula. | 1 year and 3 years after first dose date |
| Objective Response Rate (ORR) | The ORR is defined as the percentage of participants who have a complete response or partial response before surgery as assessed by the investigator per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) in all participants with measurable disease at baseline. Tumor response was assessed by computed tomography (CT) or magnetic resonance imaging (MRI) of the neck, chest, and abdomen. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | ORR was assessed prior to surgery, Day 71 to 86 |
| Number Of Participants Experiencing Treatment-Emergent Adverse Events | Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab | From the first dose of study drug up to 30 days after last dose of any component of treatment or surgery or the initiation of subsequent anticancer therapy, whichever occurred first. Up to approximately 9 months. |
| Fuzhou |
| Fujian |
| 350001 |
| China |
| The Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050011 | China |
| Union Hospital of Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
| Tangdu Hospital | Xi'an | Shaanxi | 710038 | China |
| Affiliated Zhongshan Hospital of Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| BG001 | Cohort B (Non-responder) | Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in PET SUVmax < 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and investigator-chosen chemotherapy doublet (paclitaxel + cisplatin or 5-fluorouracil + cisplatin) for 2 cycles plus concurrent radiotherapy. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Cohort B (Non-responder) | Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in PET SUVmax < 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and investigator-chosen chemotherapy doublet (paclitaxel + cisplatin or 5-fluorouracil + cisplatin) for 2 cycles plus concurrent radiotherapy. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later. |
|
|
| Secondary | R0 Resection Rate | Defined as the percentage of participants with R0 resection. R0 resection refers to a surgical procedure where the entire tumor is completely removed with no evidence of residual cancer tissue at the surgical margins. | The Efficacy Evaluable Analysis Set included all participants who received neoadjuvant treatment followed by surgery. | Posted | Number | percentage of participants | Resection was planned to occur 4-6 weeks after the last dose of chemotherapy, approximately Day 71-86 |
|
|
|
| Secondary | 1-year/3-year Disease-free Survival (DFS) Rate | The DFS rate is defined as the percentage of participants free from disease events at 1 year and 3 years after the first date of no disease (R0 resection as surgery outcome). Disease events include local or distant recurrence or death due to any cause. The DFS rate was analyzed only for participants who underwent R0 resection. Disease-free rates were estimated using the Kaplan-Meier method with 95% confidence intervals estimated using the Greenwood formula. | The Efficacy Evaluable Analysis Set with R0 resection included all participants who received neoadjuvant treatment followed by surgery with R0 resection. No participants were on follow-up for 3 years after surgery, so DFS rate at 3 years was not assessed. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year and 3 years after surgery |
|
|
|
| Secondary | 1-year/3-year Event-free Survival (EFS) Rate | The EFS rate is defined as the percentage of participants free from EFS events at 1 year and 3 years after the first dose. The EFS events include progression of disease that precludes definitive surgery, local or distant recurrence, or death due to any cause. Event-free rates were estimated using the Kaplan-Meier method with 95% confidence intervals estimated using the Greenwood formula. | The Safety Analysis Set included all participants who received at least one dose of any component of study drugs. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year and 3 years after first dose date |
|
|
|
| Secondary | Objective Response Rate (ORR) | The ORR is defined as the percentage of participants who have a complete response or partial response before surgery as assessed by the investigator per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) in all participants with measurable disease at baseline. Tumor response was assessed by computed tomography (CT) or magnetic resonance imaging (MRI) of the neck, chest, and abdomen. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | The Safety Analysis Set with Measurable Disease at Baseline included all participants who had measurable disease at baseline and received at least one dose of any component of study drugs. | Posted | Number | 95% Confidence Interval | percentage of participants | ORR was assessed prior to surgery, Day 71 to 86 |
|
|
|
| Secondary | Number Of Participants Experiencing Treatment-Emergent Adverse Events | Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab | The Safety Analysis Set included all participants who received at least one dose of any component of study drugs. | Posted | Count of Participants | Participants | From the first dose of study drug up to 30 days after last dose of any component of treatment or surgery or the initiation of subsequent anticancer therapy, whichever occurred first. Up to approximately 9 months. |
|
|
|
| 8 |
| 30 |
| 8 |
| 30 |
| 30 |
| 30 |
| EG001 | Cohort B (Non-responder) | Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in PET SUVmax < 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and investigator-chosen chemotherapy doublet (paclitaxel + cisplatin or 5-fluorouracil + cisplatin) for 2 cycles plus concurrent radiotherapy. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later. | 17 | 40 | 12 | 40 | 39 | 40 |
| Acute coronary syndrome | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
|
| Immune-mediated myocarditis | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| COVID-19 pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Anastomotic fistula | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
|
| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
|
| Radiation oesophagitis | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
|
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Tracheal fistula | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 27.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Oesophageal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Eye infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
|
| Radiation oesophagitis | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Alpha hydroxybutyrate dehydrogenase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Bile acids increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Blood magnesium decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Monocyte count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
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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.
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
| 3 Years |
|