Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CTR20160890 | Registry Identifier | ChinaDrugTrials.org |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This was a single-arm, open-label, multi-center Phase 2 study in participants with histologically documented CLL/SLL who have relapsed after or refractory to ≥ 1 prior treatment regimen(s). The study is composed of an initial screening phase, a single-arm treatment phase, and a follow-up phase.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zanubrutinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zanubrutinib | Drug | Zanubrutinib 160 mg (two - 80 mg white opaque capsules) taken by mouth (PO) twice a day (BID) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) by Independent Review Committee (IRC) | ORR is defined as the number of participants who achieve a best response of CR or, CRi, Nodular Partial Response, PR, and PR with Lymphocytosis as assessed by IRC per the modified IWCLL Guidelines in participants with CLL and the Revised Criteria for Response for Malignant Lymphoma in participants with SLL. | Up to 1 year and 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS): Percentage of Participants Progression/Death Event Free | PFS is defined as the time from treatment initiation to first documentation of progression by International workshop on chronic lymphocytic leukemia (IWCLL) criteria/revised criteria for response for malignant lymphoma or death, whichever is earlier. | 6, 12, 24, and 36 months |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Peoples Hospital | Beijing | Beijing Municipality | 100044 | China | ||
| Peking Union Medical College Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32393328 | Result | Xu W, Yang S, Zhou K, Pan L, Li Z, Zhou J, Gao S, Zhou D, Hu J, Feng R, Huang H, Ji M, Guo H, Huang J, Novotny W, Feng S, Li J. Treatment of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma with the BTK inhibitor zanubrutinib: phase 2, single-arm, multicenter study. J Hematol Oncol. 2020 May 11;13(1):48. doi: 10.1186/s13045-020-00884-4. | |
| 38502198 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
91 participants were enrolled at 11 sites in China. The first participant was dosed on 09 March 2017. Database lock date for the primary outcome measure was 14 December 2018. Final database lock date was 16 October 2020.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Zanubrutinib | 160 mg administered orally (two - 80 mg white opaque capsules) twice a day (BID) for up to three years or until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by the sponsor. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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 | Oct 25, 2017 | Aug 10, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Duration of Response (DOR): Event Free Rate - Percentage of Participants Who Remained Event Free | DOR is defined as the time from the date that response criteria are first met to the date that progressive disease (PD) is objectively documented or death, whichever occurs first | 6, 12, 24, and 36 months |
| Time to Response (TTR) | TTR is defined as the time from treatment initiation to first signs of response | Up to 3.5 years |
| Overall Response Rate as Determined by the Investigator | Overall response was defined as achieving a best overall response of CR, CRi, nodular partial response (nPR), PR, or partial response with lymphocytosis (PR-L). | up to 3.5 years |
| Number of Participants Experiencing Adverse Events (AEs) | An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All AEs were monitored per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version [v] 4.03 2010). A treatment emergent adverse event (TEAE) is defined as an adverse event that has an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation or initiation of new anticancer therapy, whichever occurs first. | Up to 3.5 years |
| Beijing |
| Beijing Municipality |
| 100730 |
| China |
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350001 | China |
| Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | 510515 | 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 Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
| Institute of Hematology and Hospital of Blood Disease | Tianjin | Tianjin Municipality | 300020 | China |
| Moslehi JJ, Furman RR, Tam CS, Salem JE, Flowers CR, Cohen A, Zhang M, Zhang J, Chen L, Ma H, Brown JR. Cardiovascular events reported in patients with B-cell malignancies treated with zanubrutinib. Blood Adv. 2024 May 28;8(10):2478-2490. doi: 10.1182/bloodadvances.2023011641. |
| 36799536 | Derived | Xu W, Yang S, Zhou K, Pan L, Li Z, Gao S, Zhou D, Hu J, Feng R, Huang H, Wang T, Li D, Ji M, Guo H, Zhao X, Wu B, Yu Y, Wang Y, Huang J, Novotny W, Li J. Zanubrutinib in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma: final results and correlative analysis of lymphocytosis. Leuk Lymphoma. 2023 Mar;64(3):712-716. doi: 10.1080/10428194.2022.2164692. Epub 2023 Feb 17. No abstract available. |
| 35900694 | Derived | Xu W, Yang S, Tam CS, Seymour JF, Zhou K, Opat S, Qiu L, Sun M, Wang T, Trotman J, Pan L, Gao S, Zhou J, Zhou D, Zhu J, Song Y, Hu J, Feng R, Huang H, Su D, Shi M, Li J. Zanubrutinib Monotherapy for Naive and Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: A Pooled Analysis of Three Studies. Adv Ther. 2022 Sep;39(9):4250-4265. doi: 10.1007/s12325-022-02238-7. Epub 2022 Jul 28. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set: All participants who received any dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Zanubrutinib | 160 mg administered orally (two - 80 mg white opaque capsules) twice a day (BID) for up to three years or until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by the sponsor. |
| 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 |
| ||||||||||||||||||||||
| Age, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate (ORR) by Independent Review Committee (IRC) | ORR is defined as the number of participants who achieve a best response of CR or, CRi, Nodular Partial Response, PR, and PR with Lymphocytosis as assessed by IRC per the modified IWCLL Guidelines in participants with CLL and the Revised Criteria for Response for Malignant Lymphoma in participants with SLL. | Modified Safety Analysis Set: All participants in the safety analysis set who had confirmed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) | Posted | Count of Participants | Participants | Up to 1 year and 4 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS): Percentage of Participants Progression/Death Event Free | PFS is defined as the time from treatment initiation to first documentation of progression by International workshop on chronic lymphocytic leukemia (IWCLL) criteria/revised criteria for response for malignant lymphoma or death, whichever is earlier. | The Safety Analysis Set included all participants who received ≥ 1 doses of study drug. All efficacy analyses were based on the Safety Analysis Set | Posted | Median | 95% Confidence Interval | Percentage of participants | 6, 12, 24, and 36 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR): Event Free Rate - Percentage of Participants Who Remained Event Free | DOR is defined as the time from the date that response criteria are first met to the date that progressive disease (PD) is objectively documented or death, whichever occurs first | The Safety Analysis Set included all participants who received ≥ 1 doses of study drug. Duration of response was summarized for responders (with Best Overall Response of partial response with lymphocytosis (PR-L) or above) only | Posted | Median | 95% Confidence Interval | Percentage of participants | 6, 12, 24, and 36 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) | TTR is defined as the time from treatment initiation to first signs of response | The Safety Analysis Set included all participants who received ≥ 1 doses of study drug. Time to response was summarized for responders (those who achieved a best overall response of at least PR-L) only | Posted | Median | Full Range | Months | Up to 3.5 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate as Determined by the Investigator | Overall response was defined as achieving a best overall response of CR, CRi, nodular partial response (nPR), PR, or partial response with lymphocytosis (PR-L). | The Safety Analysis Set included all participants who received ≥ 1 doses of study drug. | Posted | Median | 95% Confidence Interval | Percentage of participants | up to 3.5 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing Adverse Events (AEs) | An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All AEs were monitored per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version [v] 4.03 2010). A treatment emergent adverse event (TEAE) is defined as an adverse event that has an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation or initiation of new anticancer therapy, whichever occurs first. | The Safety Analysis Set included all participants who received ≥ 1 doses of study drug. | Posted | Count of Participants | Participants | Up to 3.5 years |
|
|
Up to 3.5 years
Safety Analysis Set
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 | Zanubrutinib | 160 mg administered orally (two - 80 mg white opaque capsules) twice a day (BID) for up to three years | 11 | 91 | 47 | 91 | 91 | 91 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Anorectal infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Dermatitis infected | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Hepatitis B | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Splenic infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Intestinal polyp | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Cryptococcosis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Brain herniation | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Periprosthetic fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Osteoarthropathy | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Cerebrovascular insufficiency | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (23.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Bacterial test positive | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood fibrinogen decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Carbon dioxide increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Neutrophil percentage decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Red blood cells urine positive | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Urobilinogen urine increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Periodontal disease | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Asymptomatic bacteriuria | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Hepatitis B reactivation | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Low density lipoprotein decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Bacterial test positive | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Hepatitis B core antibody positive | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| High density lipoprotein decreased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Globulins decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| High density lipoprotein increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| White blood cells urine positive | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Blood immunoglobulin A decreased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Carbon dioxide decreased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Urine leukocyte esterase positive | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Skin haemorrhage | Skin and subcutaneous tissue 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | BeiGene | +1-877-828-5568 | clinicaltrials@beigene.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 16, 2018 | Aug 10, 2020 | SAP_000.pdf |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
| ID | Term |
|---|---|
| C000629551 | zanubrutinib |
Not provided
Not provided
Not provided
|
|
|
|
|