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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002980-33 | EudraCT Number |
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This study evaluated the safety, efficacy and clinical benefit of BGB-3111 (zanubrutinib) vs ibrutinib in participants with MYD88 Mutation Waldenström's Macroglobulinemia.
This open-label, randomized study compared the efficacy and safety of the Bruton's Tyrosine Kinase (BTK) inhibitors BGB-3111 and ibrutinib in participants with Waldenström's Macroglobulinemia who require therapy. Participants had baseline bone marrow samples assayed for sequencing of the MYD88 gene. 201 participants with the MYD88 mutation were enrolled and randomized to receive 160 mg BGB-3111 orally twice per day (PO BID) (treatment Arm A) or to receive 420mg ibrutinib orally once per day (PO QD) (treatment Arm B) until disease progression or unacceptable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A : Ibrutinib | Experimental | Participants with the MYD88 mutation received Ibrutinib |
|
| Arm B: Zanubrutinib | Active Comparator | Participants with the MYD88 mutation received zanubrutinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGB-3111 | Drug | 160 mg PO BID until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Either a Complete Response (CR) or Very Good Partial Response (VGPR) Using an Adaptation of the Response Criteria Updated at the Sixth International Workshop on WM as Assessed by an Independent Review Committee (IRC) | Percentage of participants with CR, defined as normal serum immunoglobulin M (IgM) levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at baseline, or VGPR, defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values. | Up to approximately 2 years and 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Major Response Rate (MRR) as Assessed by IRC | MRR defined as the percentage of participants achieving a best response of response of CR, defined as normal serum IgM levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at baseline, VGPR, defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values or partial response (PR) defined as ≥50% reduction of serum IgM from baseline. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Phoenix | Phoenix | Arizona | 85254 | United States | ||
| City of Hope National Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29869556 | Result | Tam CS, LeBlond V, Novotny W, Owen RG, Tedeschi A, Atwal S, Cohen A, Huang J, Buske C. A head-to-head Phase III study comparing zanubrutinib versus ibrutinib in patients with Waldenstrom macroglobulinemia. Future Oncol. 2018 Sep;14(22):2229-2237. doi: 10.2217/fon-2018-0163. Epub 2018 Jun 5. | |
| 40924923 | Derived |
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The screening period consisted of Days -35 to -1.
A total of 201 participants were randomized to Arm A and Arm B in 12 countries in Australia, Europe, United Kingdom and United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Ibrutinib | Participants diagnosed with Waldenström's Macroglobulinemia (WM) with mutated MYD88 gene received 420 mg ibrutinib once daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor |
| FG001 | Arm B: Zanubrutinib |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Sep 2, 2019 | Feb 16, 2023 |
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| Ibrutinib | Drug | 420 mg PO QD until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor |
|
|
| Up to approximately 2 years and 7 months |
| Duration of Response (DOR) as Assessed by IRC | DOR defined as the time from first determination of response (CR, VGPR or PR) until first documentation of progression or death, whichever comes first. CR is defined as normal serum IgM levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at baseline, VGPR, is defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values or partial response (PR) is defined as ≥50% reduction of serum IgM from baseline. | Up to approximately 2 years and 7 months |
| DOR as Assessed by IRC: Event -Free Rate | Estimated percentage of participants who were event-free based on Kaplan-Meier method. | 12 and 18 months from the date of randomization (up to approximately 2 years and 7 months) |
| Percentage of Participants Achieving Either CR or VGPR in as Assessed by the Investigator | Percentage of participants with CR, defined as normal serum IgM levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at Baseline, or VGPR, defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values. | Up to approximately 5 years and 5 months |
| DOR as Assessed by the Investigator | DOR is defined as the time from first determination of response (CR, VGPR or PR) until first documentation of progression or death, whichever comes first | Up to approximately 5 years and 5 months |
| DOR as Assessed by the Investigator: Event-Free Rate | Estimated percentage of participants who were event-free based on Kaplan-Meier method. | 24,36 and 48 months from the date of randomization (up to approximately 5 years and 5 months) |
| Progression Free Survival (PFS) as Assessed by the IRC | PFS as assessed by the IRC, defined as time from randomization to the first documentation of progression (per modified International Workshop on Waldenström macroglobulinemia [IWWM criteria]) or death, whichever occurs first | Up to approximately 2 years and 7 months |
| PFS as Assessed by IRC: Event-Free Rate | Estimated percentage of participants who were event-free based on Kaplan-Meier method | 12 and 18 months from the date of randomization (up to approximately 2 years and 7 months) |
| PFS as Assessed by the Investigator | PFS as assessed by the Investigator, defined as time from randomization to the first documentation of progression (per modified IWWM criteria) or death, whichever occurs first. | Up to approximately 5 years and 5 months |
| PFS as Assessed by the Investigator: Event-Free Rate | Percentage of participants who were event-free based on Kaplan-Meier method. | 24,36 and 48 months from the date of randomization (up to approximately 5 years and 5 months) |
| Percentage of Participants With Resolution of All Treatment-precipitating Symptoms | Up to approximately 5 years and 5 months |
| Percentage of Participants With an Anti-Lymphoma Effect | Anti-Lymphoma Effect is defined as any reduction in bone marrow involvement by lymphoplasmacytoid lymphocytes and/or size of lymphadenopathy and/or splenomegaly by CT scan, at any time during the course of study treatment. | Up to approximately 5 years and 5 months |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to approximately 5 years and 5 months |
| Duarte |
| California |
| 91010 |
| United States |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Sarah Cannon Cancer Center | Nashville | Tennessee | 37203 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Paratus Clinical Research Woden | Canberra | Australian Capital Territory | 2606 | Australia |
| St George Hospital | Kogarah | New South Wales | 2217 | Australia |
| Royal North Shore Hospital | St Leonards | New South Wales | 2065 | Australia |
| Princess Alexandra Hospital | Brisbane | Queensland | 4102 | Australia |
| Flinders Medical Centre | Bedford PK | South Australia | 5042 | Australia |
| Monash Health | Clayton | Victoria | 3168 | Australia |
| St Vincents Hospital Melbourne | Fitzroy | Victoria | 3065 | Australia |
| Peninsula Health Frankston | Frankston | Victoria | 3199 | Australia |
| Barwon Health the Geelong Hospital | Geelong | Victoria | 3220 | Australia |
| Peter Maccallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | 6009 | Australia |
| Fakultni Nemocnice Hradec Kralove | Hradec Králové | 50005 | Czechia |
| Fakultni Nemocnice Ostrava | Ostrava | 708 00 | Czechia |
| Vseobecna Fakultni Nemocnice V Praze | Prague | 10000 | Czechia |
| Centre Leon Berard | Lyon | 69373 | France |
| Srh Kliniken Landkreis Sigmaringen | Sigmaringen | 72488 | Germany |
| Universitaetsklinikum Ulm, Innere Medizin Iii | Ulm | 89081 | Germany |
| General Hospital of Athens Alexandra | Athens | 11528 | Greece |
| Policlinico Sorsola Malpighi, Aou Di Bologna | Bologna | 40138 | Italy |
| Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia | Brescia | 25123 | Italy |
| Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst | Meldola | 47014 | Italy |
| Niguarda Cancer Center Division of Hematology | Milan | 20162 | Italy |
| Aou Maggiore Della Carita | Novara | 28100 | Italy |
| Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi | Pavia | 27100 | Italy |
| Unita Di Ematologia, Dipartimento Di Ematologia Ed Oncologia | Ravenna | 48121 | Italy |
| Fondazione Policlinico A Gemelli | Roma | 168 | Italy |
| Ao Citta Della Salute E Della Scienza Di Torino Presidio O | Torino | 10126 | Italy |
| Aou Santa Maria Della Misericordia Di Udine | Udine | 33100 | Italy |
| Amsterdam Umc Amc | Amsterdam | 1105 AZ | Netherlands |
| Universitair Medisch Centrum Utrecht | Utrecht | 3584 CX | Netherlands |
| Uniwersytecki Szpital Kliniczny W Bialymstoku | Bialystok | 15-276 | Poland |
| Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny | Brzozów | 36-200 | Poland |
| Szpital Uniwersytecki Nr Im Dr Jana Biziela | Bydgoszcz | 85-168 | Poland |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich | Chorzów | 41-500 | Poland |
| Malopolskie Centrum Medyczne Sc | Krakow | 30-510 | Poland |
| Hospital Universitari Germans Trias I Pujol | Badalona | 08916 | Spain |
| Hospital de La Santa Creu I Sant Pau | Barcelona | 08025 | Spain |
| Hospital Universitario Vall Dhebron | Barcelona | 08035 | Spain |
| Ico H Duran I Reynals | Barcelona | 08907 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 8036 | Spain |
| Start Madrid Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Universitari I Politecnic La Fe | Valencia | 46026 | Spain |
| Karolinska Universitetssjukhuset Solna | Stockholm | 171 76 | Sweden |
| The Royal Bournemouth and Christchurch Hospitals Nhs Foundation | Bournemouth | BH7 7DW | United Kingdom |
| Churchill Hospital Oxford University Hospital Nhs Trust | Headington | OX3 7LE | United Kingdom |
| St Jamess Institute of Oncology | Leeds | LS9 7LP | United Kingdom |
| Barts Health Nhs Trust | London | EC1A 7BE | United Kingdom |
| University College Hospital | London | NW1 2PG | United Kingdom |
| Nottingham University Hospitals Nhs Trust | Nottingham | NG51PB | United Kingdom |
| Plymouth Hospitals Nhs Trust | Plymouth | PL6 8DH | United Kingdom |
| Garcia-Sanz R, Owen RG, Jurczak W, Dimopoulos MA, McCarthy H, Cull G, Opat SS, Castillo JJ, Kersten MJ, Wahlin BE, Grosicki S, Prathikanti R, Tian T, Allewelt H, Cohen AC, Tam CS. Outcomes after transition from ibrutinib to zanubrutinib in patients with Waldenstrom macroglobulinemia from the ASPEN study. Blood Adv. 2025 Dec 23;9(24):6538-6546. doi: 10.1182/bloodadvances.2024015596. |
| 39626287 | Derived | Heyman BM, Opat SS, Wahlin BE, Dimopoulos MC, Castillo JJ, Tedeschi A, Tam CS, Buske C, Owen RG, Leblond V, Trotman J, Barnes G, Chan WY, Schneider J, Allewelt H, Cohen A, Matous JV. Peripheral neuropathy in the phase 3 ASPEN study of Bruton tyrosine kinase inhibitors for Waldenstrom macroglobulinemia. Blood Adv. 2025 Feb 25;9(4):722-728. doi: 10.1182/bloodadvances.2024014115. |
| 39072392 | Derived | Tedeschi A, Tam CS, Owen RG, Buske C, Leblond V, Dimopoulos M, Garcia-Sanz R, Castillo JJ, Trotman J, Treon SP, Yang K, Tang B, Allewelt H, Patel S, Chan WY, Cohen A, Chen S, Barnes G. Health-related quality of life in patients with Waldenstrom macroglobulinemia: results from the ASPEN trial. Future Oncol. 2024;20(25):1789-1798. doi: 10.1080/14796694.2024.2355079. Epub 2024 Jul 29. |
| 38502198 | Derived | 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. |
| 37478390 | Derived | Dimopoulos MA, Opat S, D'Sa S, Jurczak W, Lee HP, Cull G, Owen RG, Marlton P, Wahlin BE, Garcia-Sanz R, McCarthy H, Mulligan S, Tedeschi A, Castillo JJ, Czyz J, Fernandez de Larrea C, Belada D, Libby E, Matous J, Motta M, Siddiqi T, Tani M, Trneny M, Minnema MC, Buske C, Leblond V, Treon SP, Trotman J, Chan WY, Schneider J, Allewelt H, Patel S, Cohen A, Tam CS. Zanubrutinib Versus Ibrutinib in Symptomatic Waldenstrom Macroglobulinemia: Final Analysis From the Randomized Phase III ASPEN Study. J Clin Oncol. 2023 Nov 20;41(33):5099-5106. doi: 10.1200/JCO.22.02830. Epub 2023 Jul 21. |
Participants diagnosed with WM with mutated MYD88 gene received 160 milligrams (mg) zanubrutinib twice daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor |
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| NOT COMPLETED |
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Intent to Treat (ITT) Analysis Set: Includes all randomized participants assigned to an arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Ibrutinib | Participants diagnosed with WM with mutated MYD88 gene received 420 mg ibrutinib once daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor |
| BG001 | Arm B: Zanubrutinib | Participants diagnosed with WM with mutated MYD88 gene received 160 mg zanubrutinib twice daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Percentage of Participants Achieving Either a Complete Response (CR) or Very Good Partial Response (VGPR) Using an Adaptation of the Response Criteria Updated at the Sixth International Workshop on WM as Assessed by an Independent Review Committee (IRC) | Percentage of participants with CR, defined as normal serum immunoglobulin M (IgM) levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at baseline, or VGPR, defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values. | Intent To Treat (ITT) Analysis Set | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 2 years and 7 months |
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| Secondary | Percentage of Participants Achieving Major Response Rate (MRR) as Assessed by IRC | MRR defined as the percentage of participants achieving a best response of response of CR, defined as normal serum IgM levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at baseline, VGPR, defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values or partial response (PR) defined as ≥50% reduction of serum IgM from baseline. | ITT Analysis Set | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 2 years and 7 months |
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| Secondary | Duration of Response (DOR) as Assessed by IRC | DOR defined as the time from first determination of response (CR, VGPR or PR) until first documentation of progression or death, whichever comes first. CR is defined as normal serum IgM levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at baseline, VGPR, is defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values or partial response (PR) is defined as ≥50% reduction of serum IgM from baseline. | ITT Analysis Set | Posted | Median | 95% Confidence Interval | Months | Up to approximately 2 years and 7 months |
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| Secondary | DOR as Assessed by IRC: Event -Free Rate | Estimated percentage of participants who were event-free based on Kaplan-Meier method. | ITT Analysis Set | Posted | Number | 95% Confidence Interval | Percentage of Participants | 12 and 18 months from the date of randomization (up to approximately 2 years and 7 months) |
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| Secondary | Percentage of Participants Achieving Either CR or VGPR in as Assessed by the Investigator | Percentage of participants with CR, defined as normal serum IgM levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at Baseline, or VGPR, defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values. | ITT Analysis Set | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 5 years and 5 months |
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| Secondary | DOR as Assessed by the Investigator | DOR is defined as the time from first determination of response (CR, VGPR or PR) until first documentation of progression or death, whichever comes first | ITT Analysis Set | Posted | Median | 95% Confidence Interval | Months | Up to approximately 5 years and 5 months |
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| Secondary | DOR as Assessed by the Investigator: Event-Free Rate | Estimated percentage of participants who were event-free based on Kaplan-Meier method. | ITT Analysis Set | Posted | Number | 95% Confidence Interval | Percentage of Participants | 24,36 and 48 months from the date of randomization (up to approximately 5 years and 5 months) |
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| Secondary | Progression Free Survival (PFS) as Assessed by the IRC | PFS as assessed by the IRC, defined as time from randomization to the first documentation of progression (per modified International Workshop on Waldenström macroglobulinemia [IWWM criteria]) or death, whichever occurs first | ITT Analysis Set | Posted | Median | 95% Confidence Interval | Months | Up to approximately 2 years and 7 months |
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| Secondary | PFS as Assessed by IRC: Event-Free Rate | Estimated percentage of participants who were event-free based on Kaplan-Meier method | ITT Analysis Set | Posted | Number | 95% Confidence Interval | Percentage of Participants | 12 and 18 months from the date of randomization (up to approximately 2 years and 7 months) |
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| Secondary | PFS as Assessed by the Investigator | PFS as assessed by the Investigator, defined as time from randomization to the first documentation of progression (per modified IWWM criteria) or death, whichever occurs first. | ITT Analysis Set | Posted | Median | 95% Confidence Interval | Months | Up to approximately 5 years and 5 months |
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| Secondary | PFS as Assessed by the Investigator: Event-Free Rate | Percentage of participants who were event-free based on Kaplan-Meier method. | ITT Analysis Set | Posted | Number | 95% Confidence Interval | Percentage of Participants | 24,36 and 48 months from the date of randomization (up to approximately 5 years and 5 months) |
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| Secondary | Percentage of Participants With Resolution of All Treatment-precipitating Symptoms | ITT Analysis Set | Posted | Number | Percentage of Participants | Up to approximately 5 years and 5 months |
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| Secondary | Percentage of Participants With an Anti-Lymphoma Effect | Anti-Lymphoma Effect is defined as any reduction in bone marrow involvement by lymphoplasmacytoid lymphocytes and/or size of lymphadenopathy and/or splenomegaly by CT scan, at any time during the course of study treatment. | ITT Analysis Set | Posted | Number | Percentage of Participants | Up to approximately 5 years and 5 months |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Safety Analysis Set includes all participants who received any dose of zanubrutinib or ibrutinib | Posted | Number | Number of Participants | Up to approximately 5 years and 5 months |
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up to approximately 5 years and 5 months
The Safety Analysis Set included all participants who received any dose of zanubrutinib or ibrutinib. Intent To Treat analysis set included all participants that were randomized. All-Cause Mortality was assessed in Intent To Treat Analysis Set. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed in Safety Analysis Set.
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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 | Arm A: Ibrutinib | Participants diagnosed with WM with mutated MYD88 gene received 420 mg ibrutinib once daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor | 19 | 99 | 50 | 98 | 96 | 98 |
| EG001 | Arm B: Zanubrutinib | Participants diagnosed with WM with mutated MYD88 gene received 160 mg zanubrutinib twice daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor | 14 | 102 | 59 | 101 | 99 | 101 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | meddra 24.0 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | meddra 24.0 | Systematic Assessment |
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| Haemolytic anaemia | Blood and lymphatic system disorders | meddra 24.0 | Systematic Assessment |
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| Haemorrhagic disorder | Blood and lymphatic system disorders | meddra 24.0 | Systematic Assessment |
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| Hyperviscosity syndrome | Blood and lymphatic system disorders | meddra 24.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | meddra 24.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | meddra 24.0 | Systematic Assessment |
| |
| Acute left ventricular failure | Cardiac disorders | meddra 24.0 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | meddra 24.0 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Aortic valve incompetence | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Aortic valve stenosis | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Cardiomegaly | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Pericardial haemorrhage | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Diplopia | Eye disorders | meddra 24.0 | Systematic Assessment |
| |
| Eye haemorrhage | Eye disorders | meddra 24.0 | Systematic Assessment |
| |
| Anal inflammation | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Oral blood blister | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Pancreatic disorder | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Death | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | meddra 24.0 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | meddra 24.0 | Systematic Assessment |
| |
| Amyloidosis | Immune system disorders | meddra 24.0 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Brain abscess | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Cryptococcal fungaemia | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Endocarditis bacterial | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Gastroenteritis rotavirus | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Neurocryptococcosis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Post procedural sepsis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Post-acute COVID-19 syndrome | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Postoperative abscess | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Streptococcal endocarditis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Periorbital haematoma | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Stress fracture | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Interferon gamma release assay positive | Investigations | meddra 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | meddra 24.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | meddra 24.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | meddra 24.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24.0 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24.0 | Systematic Assessment |
| |
| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24.0 | Systematic Assessment |
| |
| Lymphoma transformation | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24.0 | Systematic Assessment |
| |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24.0 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24.0 | Systematic Assessment |
| |
| Nodular melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24.0 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | meddra 24.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | meddra 24.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | meddra 24.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | meddra 24.0 | Systematic Assessment |
| |
| Urinary bladder haemorrhage | Renal and urinary disorders | meddra 24.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | meddra 24.0 | Systematic Assessment |
| |
| Vaginal prolapse | Reproductive system and breast disorders | meddra 24.0 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | meddra 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | meddra 24.0 | Systematic Assessment |
| |
| Increased tendency to bruise | Blood and lymphatic system disorders | meddra 24.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | meddra 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | meddra 24.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | meddra 24.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | meddra 24.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | meddra 24.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | meddra 24.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | meddra 24.0 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | meddra 24.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | meddra 24.0 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | meddra 24.0 | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | meddra 24.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | meddra 24.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Chest pain | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Chills | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Malaise | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | meddra 24.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | meddra 24.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Nail infection | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | meddra 24.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | meddra 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | meddra 24.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | meddra 24.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | meddra 24.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | meddra 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | meddra 24.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | meddra 24.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | meddra 24.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | meddra 24.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | meddra 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | meddra 24.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | meddra 24.0 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | meddra 24.0 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | meddra 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24.0 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24.0 | Systematic Assessment |
| |
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | meddra 24.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | meddra 24.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | meddra 24.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | meddra 24.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | meddra 24.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | meddra 24.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | meddra 24.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | meddra 24.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | meddra 24.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | meddra 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | meddra 24.0 | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Onychoclasis | Skin and subcutaneous tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Rosacea | Skin and subcutaneous tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Skin toxicity | Skin and subcutaneous tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | meddra 24.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | meddra 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | meddra 24.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | meddra 24.0 | Systematic Assessment |
|
BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information & may request a further delay to protect its IP rights
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | BeiGene | +1-877-828-5568 | clinicaltrials@beigene.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 21, 2019 | Feb 16, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008258 | Waldenstrom Macroglobulinemia |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000629551 | zanubrutinib |
| C551803 | ibrutinib |
Not provided
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Participants |
|
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| Participants |
|
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