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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20170119 | Registry Identifier | Center for drug evaluation, CFDA |
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The primary objective of this study was to evaluate the efficacy of tislelizumab assessed by Independent Review Committee (IRC) in participants with relapsed or refractory classical Hodgkin lymphoma (cHL), as measured by Overall Response Rate (ORR) per the Lugano Classification
This was an open-label, single-arm, multi-center Phase 2 study. Response was to be assessed by PET(positron emission tomography) and computed tomography (CT) scan per the Lugano Classification. CT scan with contrast and Positron emission tomography (PET)/CT was used as required by protocol, until progressive disease (PD), new anti-cancer therapy, withdrawal of consent, death, lost to follow-up, or end of study (EOS), whichever occurred first. Total body magnetic resonance imaging (MRI) was allowed if CT with contrast is contraindicated. During treatment with immune checkpoint inhibitor such as with tislelizumab, pseudo-progression may occur due to immune cell infiltration and other mechanisms as manifested by apparent increase of existing tumor masses or appearance of new tumor lesions. Participants were allowed to continue study treatment if there is suspicion of pseudo-progression, provided they are asymptomatic and have radiographic progression only, until a second consecutive CT scan demonstrates PD at which time study treatment was discontinued permanently. Participants were evaluated for Adverse Events (AEs) (all Grades per National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.03 [NCI CTCAE v. 4.03]), serious AEs (SAEs), and any AEs requiring study drug interruption or discontinuation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tislelizumab | Experimental | Tislelizumab 200 mg administered intravenously (IV) every-3-weeks (Q3W) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | Administered as specified in the treatment arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR is defined as the proportion of participants who achieve a best response of Complete Response (CR) or Partial Response (PR), as assessed by Independent Review committee (IRC) per the Lugano Classification | From the date of first dose Up to approximately 3 year and 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | PFS is defined as the time from the first dose of tislelizumab to the date of Progressive Disease (PD) or death, whichever occurs first, assessed by IRC per the Lugano Classification | From the date of first dose until end of study (Up to approximately 3 years and 7 months) |
Not provided
Key Inclusion Criteria:
Histologically confirmed relapsed or refractory cHL (biopsy from diagnosis or at any relapse is acceptable).
Participants must have relapsed (disease progression after most recent therapy) or refractory (failure to achieve complete Response (CR) /complete metabolic response [CMR] or partial response (PR) to most recent therapy) cHL and and failed to achieve a response or progressed after auto-SCT or meet the criteria of ineligible for auto-SCT.
Participants must have measurable disease defined as ≥ 1 nodal lesion that is > 1.5 cm in the longest diameter, or ≥ 1 extra-nodal lesion (e.g. hepatic nodules) that is > 1 cm in the longest diameter.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Life expectancy ≥ 12 weeks.
participants must have adequate organ functions as indicated by the following laboratory values:
International normalized ratio (INR) ≤ 1.5 x ULN and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy and coagulation parameters (prothrombin time [PT/INR] and aPTT) are within intended therapeutic range of intended use of the anticoagulant at time of Screening. Participants with factor inhibitors prolonging PT or INR may be included after discussion with the medical monitor.
Participants must have no evidence of dyspnea at rest and a pulse oximetry of > 92% while breathing room air.
Participants must have forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) > 60% by pulmonary function test (PFT); carbon monoxide diffusion capacity (DLCO), FEV1 and FVC all > 50 % predicted value; all PFTs must be obtained within 4 weeks prior to the first dose of tislelizumab.
Prior chemotherapy, radiotherapy, immunotherapy or investigational therapy (including Chinese herbal medicine and Chinese patent medicine) used to control cancer including locoregional treatment must have been completed ≥ 4 weeks before the first dose of tislelizumab, and all treatment-related adverse events are stable and have either returned to baseline or Grade 0/1 (except for alopecia and hemoglobin. For hemoglobin, please follow inclusion criteria #8c [hemoglobin]).
Key Exclusion Criteria:
Nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma.
Prior allogeneic hematopoietic stem cell transplant.
History of severe hypersensitivity reaction to monoclonal antibodies.
New York Heart Association (NYHA) class III or IV heart failure, unstable angina, severe uncontrolled ventricular arrhythmia, electrocardiographic evidence of acute ischemia, or myocardial infarction within 6 months of first day of Screening.
Prior malignancy within the past 3 years except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast.
Prior therapy targeting PD-1 or PD-L1.
Participants with active autoimmune disease or history of autoimmune disease with high risk of recurrence including but not limited to history of immune-related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barrè syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue disease, scleroderma, inflammatory bowel disease including Crohn's disease and ulcerative colitis, autoimmune hepatitis, toxic epidermal necrolysis (TEN), or Stevens-Johnson syndrome.
Note: Participants is permitted to enroll if he/she has vitiligo, eczema, type I diabetes mellitus, endocrine deficiencies including thyroiditis managed with replacement hormone and/or physiologic corticosteroid. Participants with rheumatoid arthritis and/or other arthropathies, Sjögren's syndrome or psoriasis controlled with topical medication, and participants with positive serology such as positive antinuclear antibody (ANA) or anti-thyroid antibody should be evaluated for presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible.
Conditions requiring systemic treatment with either corticosteroids (> 10 mg daily Prednisone equivalent) or other immunosuppressive medications within 14 days of first dose of tislelizumab.
Note: Adrenal replacement doses of ≤ 10 mg daily Prednisone are permitted in the absence of active autoimmune disease. Topical, ocular, intra-articular, intra-nasal and inhalational corticosteroid (with minimal systemic absorption), a brief course of corticosteroid for prophylaxis (e.g. contrast dye allergy) or for treatment of non-autoimmune conditions (e.g. delayed-type hypersensitivity reaction caused by contact allergen) are allowed.
Has history of interstitial lung disease or non-infectious pneumonitis or has evidence of interstitial lung disease or non infectious pneumonitis currently.
QT Interval Corrected by the Fridericia Correction Formula (QTcF)interval > 480 msec, unless secondary to bundle branch block.
Serious acute or chronic infection requiring systemic therapy.
Known central nervous system (CNS) lymphoma.
Underlying medical conditions that, in the Investigator's opinion, will render the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events.
Autologous hematopoietic stem cell transplant within 100 days of first dose of tislelizumab.
Use of any live vaccine against infectious diseases (e.g. influenza, varicella, etc.) within 4 weeks (28 days) of the first dose of tislelizumab, and any intended use within 60 days after the last dose of tislelizumab.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China | ||
| Chinese Pla General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31520078 | Result | Song Y, Gao Q, Zhang H, Fan L, Zhou J, Zou D, Li W, Yang H, Liu T, Wang Q, Lv F, Guo H, Yang L, Elstrom R, Huang J, Novotny W, Wei V, Zhu J. Treatment of relapsed or refractory classical Hodgkin lymphoma with the anti-PD-1, tislelizumab: results of a phase 2, single-arm, multicenter study. Leukemia. 2020 Feb;34(2):533-542. doi: 10.1038/s41375-019-0545-2. Epub 2019 Sep 13. | |
| 34716199 |
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70 participants were enrolled at 11 sites in China. The first participant dose date was on 21 April 2017. The study was completed on 02 November 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tislelizumab | Tislelizumab 200 mg administered intravenously (IV) every-3-weeks (Q3W) until progressive disease (PD), unacceptable toxicity, death, or study withdrawal by the participant. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set: All participants who received any dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tislelizumab | Tislelizumab 200 mg administered IV Q3W until PD, unacceptable toxicity, death, or study withdrawal by the participant. |
| 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 is defined as the proportion of participants who achieve a best response of Complete Response (CR) or Partial Response (PR), as assessed by Independent Review committee (IRC) per the Lugano Classification | Modified Safety Analysis Set: All participants in the safety analysis set who had confirmed classical Hodgkin lymphoma. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From the date of first dose Up to approximately 3 year and 7 months |
|
|
From the date of first dose until end of study (Up to approximately 3 years and 7 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 | Tislelizumab | Tislelizumab 200 mg administered intravenously (IV) every-3-weeks (Q3W) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | BeiGene | +1-877-828-5568 | clinicaltrials@beigene.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 15, 2019 | Aug 12, 2020 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 17, 2018 | Aug 12, 2020 | SAP_000.pdf |
| ID | Term |
|---|---|
| C000707970 | tislelizumab |
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| Duration of Response (DOR) |
DOR is defined as the time from the date that response criteria are first met to the date that PD is objectively documented or death, whichever occurs first, assessed by IRC per the Lugano Classification |
| From the date of first dose until end of study (Up to approximately 3 years and 7 months) |
| Rate of Complete Response (CRR) | CRR is defined as the percentage of participants who achieve a best response of CR, assessed by IRC per the Lugano Classification | From the date of first dose until end of study (Up to approximately 3 years and 7 months) |
| Time to Response (TTR) | TTR is defined as the time from the date of the first dose of tislelizumab to the time the response criteria are first met, assessed by IRC per the Lugano Classification | From the date of first dose until end of study (Up to approximately 3 years and 7 months) |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 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. An SAE is any untoward medical occurrence that, at any dose:
| From the date of first dose until end of study (Up to approximately 3 years and 7 months) |
| Number of Participants With Significant Changes in Clinical Laboratory Results | Clinical laboratory (e.g. hematology, serum chemistry, urinalysis) values were evaluated for each laboratory parameter and participants with clinically significant changes are summarized. | From the date of first dose until end of study (Up to approximately 3 years and 7 months) |
| Number of Participants With Significant Changes in Electrocardiograms | From the date of first dose until end of study (Up to approximately 3 years and 7 months) |
| Beijing |
| Beijing Municipality |
| 100853 |
| China |
| Fujian Cancer Hospital | Fuzhou | Fujian | 350014 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450000 | China |
| Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200000 | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
| Institute of Hematology and Hospital of Blood Disease | Tianjin | Tianjin Municipality | 300020 | China |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| Derived |
| Song Y, Gao Q, Zhang H, Fan L, Zhou J, Zou D, Li W, Yang H, Liu T, Wang Q, Lv F, Guo H, Zhao X, Wang D, Zhang P, Wang Y, Wang L, Liu T, Zhang Y, Shen Z, Huang J, Zhu J. Tislelizumab for Relapsed/Refractory Classical Hodgkin Lymphoma: 3-Year Follow-up and Correlative Biomarker Analysis. Clin Cancer Res. 2022 Mar 15;28(6):1147-1156. doi: 10.1158/1078-0432.CCR-21-2023. |
| 33332484 | Derived | Chen J, Zhang H, Zhu L, Zhao Y, Ding Y, Yuan Y. Tislelizumab for the treatment of classical Hodgkin's lymphoma. Drugs Today (Barc). 2020 Dec;56(12):781-785. doi: 10.1358/dot.2020.56.12.3233362. |
| Transferred to Long Term Extension (LTE) study |
|
| Sponsor Decision |
|
| Participant Withdrew Due to Higher Risk than Benefit of Treatment |
|
| Participant Refused to Return to Treatment |
|
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
|
|
| Secondary | Progression-free Survival (PFS) | PFS is defined as the time from the first dose of tislelizumab to the date of Progressive Disease (PD) or death, whichever occurs first, assessed by IRC per the Lugano Classification | Modified Safety Analysis set | Posted | Median | 95% Confidence Interval | Months | From the date of first dose until end of study (Up to approximately 3 years and 7 months) |
|
|
|
| Secondary | Duration of Response (DOR) | DOR is defined as the time from the date that response criteria are first met to the date that PD is objectively documented or death, whichever occurs first, assessed by IRC per the Lugano Classification | Modified Safety Analysis set; Participants with available data were included in the analysis. | Posted | Median | 95% Confidence Interval | Months | From the date of first dose until end of study (Up to approximately 3 years and 7 months) |
|
|
|
| Secondary | Rate of Complete Response (CRR) | CRR is defined as the percentage of participants who achieve a best response of CR, assessed by IRC per the Lugano Classification | Modified safety analysis set | Posted | Median | 95% Confidence Interval | Percentage of participants | From the date of first dose until end of study (Up to approximately 3 years and 7 months) |
|
|
|
| Secondary | Time to Response (TTR) | TTR is defined as the time from the date of the first dose of tislelizumab to the time the response criteria are first met, assessed by IRC per the Lugano Classification | Modified safety analysis set; participants with available data were included in the analysis. | Posted | Median | Full Range | Weeks | From the date of first dose until end of study (Up to approximately 3 years and 7 months) |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 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. An SAE is any untoward medical occurrence that, at any dose:
| The Safety Analysis Set included all participants who received any dose of tislelizumab. | Posted | Number | Participants | From the date of first dose until end of study (Up to approximately 3 years and 7 months) |
|
|
|
| Secondary | Number of Participants With Significant Changes in Clinical Laboratory Results | Clinical laboratory (e.g. hematology, serum chemistry, urinalysis) values were evaluated for each laboratory parameter and participants with clinically significant changes are summarized. | The Safety Analysis Set included all participants who received any dose of tislelizumab. | Posted | Number | Participants | From the date of first dose until end of study (Up to approximately 3 years and 7 months) |
|
|
|
| Secondary | Number of Participants With Significant Changes in Electrocardiograms | The Safety Analysis Set included all participants who received any dose of tislelizumab. | Posted | Number | Participants | From the date of first dose until end of study (Up to approximately 3 years and 7 months) |
|
|
|
| 8 |
| 70 |
| 18 |
| 70 |
| 68 |
| 70 |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hepatitis B | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Traumatic lung injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Focal segmental glomerulosclerosis | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Renal injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Renal tubular injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 23.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Liver injury | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Bilirubin conjugated increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Blood bilirubin unconjugated increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 23.0 | 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.
|
| Increase > 30 msec but ≤ 60 msec corrected QT interval |
|