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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002105-22 | EudraCT Number |
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| Name | Class |
|---|---|
| Lymphoma Study Association | OTHER |
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This was a Phase 2 trial evaluating the effectiveness and safety of tislelizumab in participants with relapsed or hard-to-treat classical Hodgkin lymphoma (cHL). Participants were grouped by prior treatments. The main outcome was to assess overall response rate (ORR) across both cohorts. Participants continued receiving the study treatment until their disease got worse, side effects became too severe, or they chose to stop for other reasons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression following autologous hematopoietic stem cell transplantation received tislelizumab 200 milligrams (mg) intravenously every 3 weeks. |
|
| Cohort 2 | Experimental | Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression after at least one prior systemic therapy and were not candidates for autologous or allogeneic hematopoietic stem cell transplantation received tislelizumab 200 mg intravenously every 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | 200 milligrams (mg) intravenously every 3 weeks (Q3W) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) by Positron Emission Tomography (PET) and Computed Tomography (CT) per the Lugano Classification and as determined by the investigator. CR was defined as the complete disappearance of all target lesions on PET-CT, with no new lesions detected. PR was defined as a significant reduction in metabolic activity or lesion size consistent with partial tumor shrinkage as per Lugano criteria. | From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate (CRR) | CRR was defined as the percentage of participants who achieved a best overall response of complete response (CR) by PET-CT or CT per the Lugano Classification and determined by the investigator. CR was defined as the complete disappearance of all target lesions on PET-CT or CT, with no new lesions detected. | From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months. |
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Key Inclusion Criteria:
Participants had a histologically confirmed diagnosis of relapsed or refractory classical Hodgkin lymphoma (cHL).
Participants had either:
Participants were assigned to one of two cohorts based on the following:
Cohort 1: Participants who were relapsed or refractory after prior autologous hematopoietic stem cell transplantation (HSCT):
Cohort 2: Participants who were relapsed or refractory to salvage chemotherapy and had not received prior HSCT:
Participants had measurable disease, defined as at least one positron emission tomography (PET)-positive, 2-\[18F] fluoro-2-deoxy-D-glucose (FDG)-avid nodal lesion greater than 1.5 centimeters (cm) in longest diameter, or at least one FDG-avid extranodal lesion (hepatic nodule) greater than 1.0 cm in longest diameter.
Participants had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, indicating full activity or restricted activity but capable of self-care.
Key Exclusion Criteria:
Note: Additional inclusion and exclusion criteria defined in the protocol may have applied.
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| Name | Affiliation | Role |
|---|---|---|
| Herve Ghesguieres | Lymphoma Study Association | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-2013 | United States | ||
| University of Tennessee Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Ghesquières H, López-Guillermo A, De la Cruz F, et al. Tislelizumab, an anti-PD-1 antibody, in patients with relapsed/refractory classical Hodgkin lymphoma in TIRHOL BGB-A317-210: a prospective multicenter LYSA phase 2 study conducted in Western countries. Blood. 2023;142(Suppl 1):1717. DOI:10.1182/blood-2023-188545 | ||
| Result | Ghesquières H, et al. TIRHOL (BGB-A317-210): International Phase 2 Study in Relapsed/Refractory Classical Hodgkin Lymphoma. Presented at: Congrès de la Société Française d'Hématologie (SFH); March 2024; Paris, France. | ||
| Result | Ghesquières H, López-Guillermo A, De la Cruz F, et al. Final analysis from the LYSA phase 2 TIRHOL study (BGB-A317-210): tislelizumab in relapsed/refractory classical Hodgkin lymphoma. Presented at: 18th International Conference on Malignant Lymphoma (ICML); June 18-22, 2025; Lugano, Switzerland. https://doi.org/10.1002/hon.70093_130 |
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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
After enrollment, open-label tislelizumab treatment began. Screening was completed within 28 days before the first dose. Treatment started within 14 days of eligibility confirmation, within the screening window. Treatment continued until disease progression, unacceptable toxicity, or withdrawal. Participants who did not meet eligibility criteria during screening were excluded prior to assignment to treatment groups.
This study was conducted at multiple centers across France, the United States, Belgium, and Australia from August 20, 2020, to August 29, 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression following autologous hematopoietic stem cell transplantation received tislelizumab 200 milligrams (mg) intravenously every 3 weeks. |
| FG001 | Cohort 2 | Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression after at least one prior systemic therapy and were not candidates for autologous or allogeneic hematopoietic stem cell transplantation received tislelizumab 200 mg intravenously every 3 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Safety Analysis Set included all participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression following autologous hematopoietic stem cell transplantation received tislelizumab 200 milligrams (mg) intravenously every 3 weeks. |
| BG001 |
| 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 | Overall Response Rate (ORR) | ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) by Positron Emission Tomography (PET) and Computed Tomography (CT) per the Lugano Classification and as determined by the investigator. CR was defined as the complete disappearance of all target lesions on PET-CT, with no new lesions detected. PR was defined as a significant reduction in metabolic activity or lesion size consistent with partial tumor shrinkage as per Lugano criteria. | Safety Analysis Set | Posted | Number | 95% Confidence Interval | Percentage of Participants | From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months. |
|
All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).
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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 1 | Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression following autologous hematopoietic stem cell transplantation received tislelizumab 200 milligrams (mg) intravenously every 3 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coeliac disease | Gastrointestinal 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 | Aug 23, 2023 | Aug 25, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 12, 2023 | Aug 25, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
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| Duration of Response (DOR) | DOR was defined as the time from the date that response criteria (CR or PR) were first met to the date of objectively documented disease progression or death, whichever occurred first. Participants without an event were censored at the data cutoff or end of study, whichever occurred first. Participants who received new anti-lymphoma therapies, including Hematopoietic Stem Cell Transplantation (HSCT), before having an event were censored at the date of therapy initiation. Only participants with confirmed response were included in the analysis. Median DOR was estimated using the Kaplan-Meier method. | From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months. |
| Time to Response (TTR) | TRR was defined as the time from the date of the first dose of tislelizumab to the date the response criteria were first met CR or PR per the Lugano Classification, and was analyzed only in participants who achieved an overall response; CR was defined as complete disappearance of disease, PR as ≥50% reduction in tumor burden, and Overall Response Rate (ORR) included participants with either CR or PR. | From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months. |
| Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Adverse events (AEs) were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Treatment-emergent adverse events (TEAEs) were defined as any AE that began or worsened in severity after the first dose of study treatment and up to 90 days following the last dose, regardless of initiation of new anti-lymphoma therapy. The following safety data are reported: Number of participants with any TEAEs: Participants who experienced at least one TEAE of any grade. Number of participants with any Grade ≥3 TEAEs: Participants who experienced at least one TEAE that was Grade 3 or higher in severity. Number of participants with any SAEs: Participants who experienced at least one serious adverse event, regardless of relationship to study treatment, occurring up to 90 days after the last dose. | From the date of the first dose of tislelizumab through 90 days after the last dose (maximum duration of tislelizumab exposure was 168 weeks) |
| Knoxville |
| Tennessee |
| 37920-1511 |
| United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112-5550 | United States |
| Monash Health | Clayton | Victoria | VIC 3168 | Australia |
| Withdrawal by Subject |
|
| Protocol Deviation |
|
| Cohort 2 |
Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression after at least one prior systemic therapy and were not candidates for autologous or allogeneic hematopoietic stem cell transplantation received tislelizumab 200 mg intravenously every 3 weeks. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Patient Status at Time of Enrollment | Refractory refers to participants whose disease did not respond to their most recent prior therapy (no complete or partial response). Relapse/Progression refers to participants whose disease initially responded to prior therapy but later worsened, progressed, or returned. | Count of Participants | Participants |
|
| The Eastern Cooperative Oncology Group (ECOG) Performance Status | The Eastern Cooperative Oncology Group (ECOG) Performance Status is a standard scale used to assess how a participant's disease impacts their daily living abilities. It ranges from 0 (fully active) to 5 (dead), with higher scores indicating greater functional impairment. | Count of Participants | Participants |
|
| Number of prior lines of therapy for cHL | Count of Participants | Participants |
|
| OG001 | Cohort 2 | Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression after at least one prior systemic therapy and were not candidates for autologous or allogeneic hematopoietic stem cell transplantation received tislelizumab 200 mg intravenously every 3 weeks. |
| OG002 | Total | Participants received tislelizumab 200 mg intravenously every 3 weeks. |
|
|
|
| Secondary | Complete Response Rate (CRR) | CRR was defined as the percentage of participants who achieved a best overall response of complete response (CR) by PET-CT or CT per the Lugano Classification and determined by the investigator. CR was defined as the complete disappearance of all target lesions on PET-CT or CT, with no new lesions detected. | Safety Analysis Set | Posted | Number | 95% Confidence Interval | Percentage of Participants | From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months. |
|
|
|
| Secondary | Duration of Response (DOR) | DOR was defined as the time from the date that response criteria (CR or PR) were first met to the date of objectively documented disease progression or death, whichever occurred first. Participants without an event were censored at the data cutoff or end of study, whichever occurred first. Participants who received new anti-lymphoma therapies, including Hematopoietic Stem Cell Transplantation (HSCT), before having an event were censored at the date of therapy initiation. Only participants with confirmed response were included in the analysis. Median DOR was estimated using the Kaplan-Meier method. | The responder analysis set only included participants with a confirmed response (CR) or partial response (PR). | Posted | Median | 95% Confidence Interval | months | From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months. |
|
|
|
| Secondary | Time to Response (TTR) | TRR was defined as the time from the date of the first dose of tislelizumab to the date the response criteria were first met CR or PR per the Lugano Classification, and was analyzed only in participants who achieved an overall response; CR was defined as complete disappearance of disease, PR as ≥50% reduction in tumor burden, and Overall Response Rate (ORR) included participants with either CR or PR. | Safety Analysis Set. Only participants who had achieved an overall response were included in the analysis of time to response. | Posted | Median | Full Range | months | From first dose to primary analysis data cutoff (12 Dec 2022) or new anti-lymphoma therapy start, whichever came first. Median follow-up was 11.4 months. |
|
|
|
| Secondary | Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Adverse events (AEs) were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Treatment-emergent adverse events (TEAEs) were defined as any AE that began or worsened in severity after the first dose of study treatment and up to 90 days following the last dose, regardless of initiation of new anti-lymphoma therapy. The following safety data are reported: Number of participants with any TEAEs: Participants who experienced at least one TEAE of any grade. Number of participants with any Grade ≥3 TEAEs: Participants who experienced at least one TEAE that was Grade 3 or higher in severity. Number of participants with any SAEs: Participants who experienced at least one serious adverse event, regardless of relationship to study treatment, occurring up to 90 days after the last dose. | Safety Analysis set | Posted | Count of Participants | Participants | From the date of the first dose of tislelizumab through 90 days after the last dose (maximum duration of tislelizumab exposure was 168 weeks) |
|
|
|
| 3 |
| 14 |
| 4 |
| 14 |
| 12 |
| 14 |
| EG001 | Cohort 2 | Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression after at least one prior systemic therapy and were not candidates for autologous or allogeneic hematopoietic stem cell transplantation received tislelizumab 200 mg intravenously every 3 weeks. | 9 | 31 | 9 | 31 | 30 | 31 |
| Chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Troponin increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Cutaneous t-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 27.0 | Systematic Assessment |
|
| Adrenocorticotropic hormone deficiency | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
|
| Autoimmune thyroiditis | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hyperadrenocorticism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
|
| Chalazion | Eye disorders | MedDRA 27.0 | Systematic Assessment |
|
| Periorbital swelling | Eye 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 |
|
| Angular cheilitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Systemic inflammatory response syndrome | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
|
| Cytokine release syndrome | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Balanoposthitis infective | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Dermo-hypodermitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Oesophageal candidiasis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Oral infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Tracheitis | 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 |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 27.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Folate deficiency | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Steroid diabetes | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
|
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Polyneuropathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Taste disorder | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Bulimia nervosa | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
|
| Calculus urethral | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
|
| Gynaecomastia | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Vitiligo | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Raynaud's phenomenon | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Superior vena cava syndrome | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Vena cava thrombosis | Vascular disorders | MedDRA 27.0 | 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.
| Number of participants with any SAEs |
|