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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20181404 | Registry Identifier | ChinaDrugTrials |
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This was an open-label, multicenter, non-randomized Phase 1b clinical trial for participants with histologically or cytologically confirmed locally advanced or metastatic tumors including non-squamous or squamous non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), ovarian cancer (OC), or melanoma.
All participants received sitravatinib 120 mg orally once daily in combination with tislelizumab 200 mg intravenously (IV) once every 3 weeks until occurrence of progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor. Participants were enrolled according to their tumor type and prior anti-programmed cell death protein-1 (PD-1)/PD-L1 antibody treatment into the following cohorts:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitravatinib + Tislelizumab | Experimental | Sitravatinib 120 mg was administered orally once daily in combination with tislelizumab 200 mg intravenously (IV) once every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitravatinib | Drug | Administered orally as a capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Number of participants with treatment-emergent AEs (TEAEs) and serious adverse events (SAEs), which includes laboratory tests, physical exams, electrocardiogram results and vital signs; TEAE was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study drug(s) up to 30 days following last dose of study drug(s) or initiation of a new anticancer therapy, whichever occurs first. | Up to approximately 4 years and 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) as determined by the investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Efficacy was evaluated by cohort, as pre-specified in the statistical analysis plan. | Up to approximately 4 years and 2 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blacktown Cancer and Haematology Centre | Blacktown | New South Wales | 2148 | Australia | ||
| Icon Cancer Foundation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Guo J, Zhou Q, Huang D, Yu X, Zhao J, Chu Q, Ma Z, Millward M, Gao B, Goh J, Markman B, Voskoboynik M, Gan H, Coward J, Chen C, Xiang X, Qui J, Xu Y, Yang L, Wu YL. A phase 1b study to assess safety, tolerability, pharmacokinetics, and preliminary antitumor activity of sitravatinib in combination with tislelizumab in patients (pts) with advanced solid tumors. Chinese Society of Clinical Oncology. 2019. | ||
| 36808075 | Background | Zhao J, Yu X, Huang D, Ma Z, Gao B, Cui J, Chu Q, Zhou Q, Sun M, Day D, Wu J, Pan H, Wang L, Voskoboynik M, Wang Z, Liu Y, Li H, Zhang J, Peng Y, Wu YL. SAFFRON-103: a phase 1b study of the safety and efficacy of sitravatinib combined with tislelizumab in patients with locally advanced or metastatic non-small cell lung cancer. J Immunother Cancer. 2023 Feb;11(2):e006055. doi: 10.1136/jitc-2022-006055. | |
| 38197138 |
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This study enrolled participants across study centers in Australia and China.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitravatinib + Tislelizumab | Sitravatinib 120 mg was administered orally once daily in combination with tislelizumab 200 mg intravenously (IV) once every 3 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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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 | Nov 20, 2019 | Nov 16, 2023 |
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| Tislelizumab | Drug | Administered intravenously |
|
|
| Duration of Response (DOR) | DOR is defined as the time from the first determination of an objective response until the first documentation of progressive disease, whichever comes first, as assessed by the investigator using RECIST v1.1. Results are reported for cohorts with responders, defined as CR or PR. Efficacy was evaluated by cohort, as pre-specified in the statistical analysis plan. | Up to approximately 4 years and 2 months |
| Disease Control Rate (DCR) | DCR is defined as the percentage of participants with best overall response as CR, PR, or stable disease (SD) as assessed by the investigator using RECIST v1.1. Efficacy was evaluated by cohort, as pre-specified in the statistical analysis plan. | Up to approximately 4 years and 2 months |
| Progression-free Survival (PFS) | PFS is defined as the time from the date of first dose to the date of first documentation of progressive disease or death, whichever comes first, as assessed by the investigator using RECIST v1.1. Efficacy was evaluated by cohort, as pre-specified in the statistical analysis plan. | Up to approximately 4 years and 2 months |
| Maximum Plasma Concentration (Cmax) for Sitravatinib | Predose and up to 24 hours post dose on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 21 (C1D21); 21 days per cycle |
| Time to Maximum Plasma Concentration (Tmax) for Sitravatinib | Predose and up to 24 hours post dose on C1D1 and C1D21; 21 days per cycle |
| Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Time Point (AUC(0-t)) for Sitravatinib | Predose and up to 24 hours post dose on C1D1 and C1D21; 21 days per cycle |
| Clearance After Oral Administration (CL/F) for Sitravatinib | Predose and up to 24 hours post dose on C1D1 and C1D21; 21 days per cycle |
| Area Under the Plasma Concentration-time Curve During the Dosing Interval (AUC(0-tau)) for Sitravatinib | Predose and up to 24 hours post dose on C1D1 and C1D21; 21 days per cycle |
| Observed Accumulation Ratio (Ro) for AUC0-tau for Sitravatinib | Presented as geometric mean ratio and confidence interval, transformed from the difference of least square means and confidence interval of the least square differences in the logarithmic scale by exponentiation | Predose and up to 24 hours post dose on C1D1 and C1D21; 21 days per cycle |
| Observed Accumulation Ratio (Ro) for Cmax for Sitravatinib | Presented as geometric mean ratio and confidence interval, transformed from the difference of least square means and confidence interval of the least square differences in the logarithmic scale by exponentiation | Predose and up to 24 hours post dose on C1D1 and C1D21; 21 days per cycle |
| South Brisbane |
| Queensland |
| 4101 |
| Australia |
| Monash Health | Clayton | Victoria | 3168 | Australia |
| Austin Health | Heidelberg | Victoria | 3084 | Australia |
| Nucleus Network | Melbourne | Victoria | 3004 | Australia |
| Linear Clinical Research | Nedlands | Western Australia | 6009 | Australia |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | 361003 | China |
| Guangdong Provincial Peoples Hospital | Guangzhou | Guangdong | 510080 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450000 | China |
| Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
| Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School | Nanjing | Jiangsu | 210008 | China |
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| The First Hospital of China Medical University | Shenyang | Liaoning | 110001 | China |
| Jinan Central Hospital | Jinan | Shandong | 250013 | China |
| Shandong Cancer Hospital | Jinan | Shandong | 250117 | China |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310016 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| Derived |
| Wang X, Pan H, Cui J, Chen X, Yoon WH, Carlino MS, Li X, Li H, Zhang J, Sun J, Guo J, Cui C. SAFFRON-103: a phase Ib study of sitravatinib plus tislelizumab in anti-PD-(L)1 refractory/resistant advanced melanoma. Immunotherapy. 2024 Mar;16(4):243-256. doi: 10.2217/imt-2023-0130. Epub 2024 Jan 10. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sitravatinib + Tislelizumab | Sitravatinib 120 mg was administered orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks |
| 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 | No |
| |||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| 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 | Number of Participants With Adverse Events (AEs) | Number of participants with treatment-emergent AEs (TEAEs) and serious adverse events (SAEs), which includes laboratory tests, physical exams, electrocardiogram results and vital signs; TEAE was defined as an adverse event that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study drug(s) up to 30 days following last dose of study drug(s) or initiation of a new anticancer therapy, whichever occurs first. | The Safety Analysis Set is defined as all participants who received at least 1 dose of any study drug (any component of the combination therapy) | Posted | Count of Participants | Participants | No | Up to approximately 4 years and 2 months |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | ORR is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) as determined by the investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Efficacy was evaluated by cohort, as pre-specified in the statistical analysis plan. | The Efficacy Evaluable Analysis Set consists of all treated participants in the Safety Analysis Set with measurable baseline assessment per RECIST 1.1 who had at least one evaluable post-baseline tumor assessment unless treatment was discontinued due to clinical disease progression or early death (within 13 weeks of the first dose date) | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 4 years and 2 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR is defined as the time from the first determination of an objective response until the first documentation of progressive disease, whichever comes first, as assessed by the investigator using RECIST v1.1. Results are reported for cohorts with responders, defined as CR or PR. Efficacy was evaluated by cohort, as pre-specified in the statistical analysis plan. | The Efficacy Evaluable Analysis Set consists of all treated participants in the Safety Analysis Set with measurable baseline assessment per RECIST 1.1 who had at least one evaluable post-baseline tumor assessment unless treatment was discontinued due to clinical disease progression or early death (within 13 weeks of the first dose date) | Posted | Median | 95% Confidence Interval | Months | Up to approximately 4 years and 2 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | DCR is defined as the percentage of participants with best overall response as CR, PR, or stable disease (SD) as assessed by the investigator using RECIST v1.1. Efficacy was evaluated by cohort, as pre-specified in the statistical analysis plan. | The Efficacy Evaluable Analysis Set consists of all treated participants in the Safety Analysis Set with measurable baseline assessment per RECIST 1.1 who had at least one evaluable post-baseline tumor assessment unless treatment was discontinued due to clinical disease progression or early death (within 13 weeks of the first dose date) | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 4 years and 2 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | PFS is defined as the time from the date of first dose to the date of first documentation of progressive disease or death, whichever comes first, as assessed by the investigator using RECIST v1.1. Efficacy was evaluated by cohort, as pre-specified in the statistical analysis plan. | The Safety Analysis Set for this endpoint is defined as all participants who received at least 1 dose of any study drug (any component of the combination therapy) and who met tumor type criteria per latest protocol amendment | Posted | Median | 95% Confidence Interval | Months | Up to approximately 4 years and 2 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Maximum Plasma Concentration (Cmax) for Sitravatinib | The Sitravatinib Pharmacokinetic (PK) Analysis Set includes all participants who contributed at least 1 quantifiable PK sample for sitravatinib | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter (ng/mL) | Predose and up to 24 hours post dose on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 21 (C1D21); 21 days per cycle |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Time to Maximum Plasma Concentration (Tmax) for Sitravatinib | The Sitravatinib PK Analysis Set includes all participants who contributed at least 1 quantifiable PK sample for sitravatinib | Posted | Median | Full Range | Hours (h) | Predose and up to 24 hours post dose on C1D1 and C1D21; 21 days per cycle |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Time Point (AUC(0-t)) for Sitravatinib | The Sitravatinib PK Analysis Set includes all participants who contributed at least 1 quantifiable PK sample for sitravatinib | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Predose and up to 24 hours post dose on C1D1 and C1D21; 21 days per cycle |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Clearance After Oral Administration (CL/F) for Sitravatinib | The Sitravatinib PK Analysis Set includes all participants who contributed at least 1 quantifiable PK sample for sitravatinib | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters/hour | Predose and up to 24 hours post dose on C1D1 and C1D21; 21 days per cycle |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Plasma Concentration-time Curve During the Dosing Interval (AUC(0-tau)) for Sitravatinib | The Sitravatinib PK Analysis Set includes all participants who contributed at least 1 quantifiable PK sample for sitravatinib | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Predose and up to 24 hours post dose on C1D1 and C1D21; 21 days per cycle |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Observed Accumulation Ratio (Ro) for AUC0-tau for Sitravatinib | Presented as geometric mean ratio and confidence interval, transformed from the difference of least square means and confidence interval of the least square differences in the logarithmic scale by exponentiation | The Sitravatinib PK Analysis Set includes all participants who contributed at least 1 quantifiable PK sample for sitravatinib | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Predose and up to 24 hours post dose on C1D1 and C1D21; 21 days per cycle |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Observed Accumulation Ratio (Ro) for Cmax for Sitravatinib | Presented as geometric mean ratio and confidence interval, transformed from the difference of least square means and confidence interval of the least square differences in the logarithmic scale by exponentiation | The Sitravatinib PK Analysis Set includes all participants who contributed at least 1 quantifiable PK sample for sitravatinib | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Predose and up to 24 hours post dose on C1D1 and C1D21; 21 days per cycle |
|
|
From the first dose up to 30 days after the last dose of study drug; Up to approximately 4 years and 2 months
An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to study drug or not.
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 | Sitravatinib + Tislelizumab | Sitravatinib 120 mg was administered orally once daily in combination with tislelizumab 200 mg intravenously (IV) once every 3 weeks | 158 | 216 | 120 | 216 | 213 | 216 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | meddra 25.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | meddra 25.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | meddra 25.0 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | meddra 25.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | meddra 25.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | meddra 25.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | meddra 25.0 | Systematic Assessment |
| |
| Immune-mediated myocarditis | Cardiac disorders | meddra 25.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | meddra 25.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | meddra 25.0 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | meddra 25.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | meddra 25.0 | Systematic Assessment |
| |
| Adrenocortical insufficiency acute | Endocrine disorders | meddra 25.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | meddra 25.0 | Systematic Assessment |
| |
| Immune-mediated hyperthyroidism | Endocrine disorders | meddra 25.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Diarrhoea haemorrhagic | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Gastrointestinal necrosis | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Malignant gastrointestinal obstruction | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Terminal ileitis | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Death | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Device related thrombosis | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Pain | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | meddra 25.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | meddra 25.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | meddra 25.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | meddra 25.0 | Systematic Assessment |
| |
| Hepatic pain | Hepatobiliary disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | meddra 25.0 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | meddra 25.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | meddra 25.0 | Systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Incarcerated parastomal hernia | Injury, poisoning and procedural complications | meddra 25.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase MB increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Troponin I increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Troponin increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 25.0 | Systematic Assessment |
| |
| Tumour invasion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 25.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | meddra 25.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | meddra 25.0 | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | meddra 25.0 | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | meddra 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | meddra 25.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | meddra 25.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | meddra 25.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | meddra 25.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | meddra 25.0 | Systematic Assessment |
| |
| Device occlusion | Product Issues | meddra 25.0 | Systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | meddra 25.0 | Systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | meddra 25.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | meddra 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Lung consolidation | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Pulmonary infarction | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Aortic dissection | Vascular disorders | meddra 25.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | meddra 25.0 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | meddra 25.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | meddra 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | meddra 25.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | meddra 25.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | meddra 25.0 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | meddra 25.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | meddra 25.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Malaise | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | meddra 25.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | meddra 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | meddra 25.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase MB increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Electrocardiogram T wave abnormal | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Urobilinogen urine increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Weight increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | meddra 25.0 | Systematic Assessment |
| |
| White blood cells urine positive | Investigations | meddra 25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | meddra 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | meddra 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | meddra 25.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | meddra 25.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | meddra 25.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | meddra 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | meddra 25.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | meddra 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | meddra 25.0 | Systematic Assessment |
|
BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information & may request a further delay to protect its IP rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | BeiGene | 1-877-828-5568 | clinicaltrials@beigene.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 9, 2023 | Nov 16, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000611865 | sitravatinib |
| C000707970 | tislelizumab |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| C1D1 |
|
| ||||
| C1D21 |
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| C1D1 |
|
| ||||
| C1D21 |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| C1D1 |
|
| ||||
| C1D21 |
|
|
|
|