This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Study to Investigate Zanubrutinib in Chinese Participants With B-cell Lymphoma (NCT03189524), a non-randomized phase 1 study. The primary outcome is Part I: Number Of Participants Experiencing Treatment-emergent Adverse Events And Treatment-emergent Serious Adverse Events.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03189524 |
| Phase | Phase 1 |
| Condition | B-cell Lymphoma |
| Allocation | Non-Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 44 |
| Arms in the primary outcome | n/a |
| Lead sponsor | BeiGene |
| Results posted | Yes |
2. Clinical Question
The clinical question was whether zanubrutinib could be evaluated for safety, tolerability, and drug exposure in Chinese participants with B-cell lymphoma across dose regimens and study stages. In the expansion stage, the study also set out to assess preliminary antitumor effects in participants with relapsed or refractory follicular lymphoma or marginal zone lymphoma. The registry record does not report an inferential efficacy result.
Population
Chinese participants with B-cell lymphoma. Part II focused on participants with relapsed or refractory follicular lymphoma or marginal zone lymphoma. The planned Part II enrollment was approximately 20 participants.
Intervention
Zanubrutinib, also identified in the registry record as BGB-3111. Part I evaluated 160 mg twice daily and 320 mg once daily; Part II used the recommended Phase 2 dose determined in Part I, described in the arm record as 160 mg twice daily.
Comparator
No randomized control group is described. The dose regimens and stages were not allocated as a like-for-like randomized comparison, so differences between their counts should not be interpreted as comparative treatment effects.
Primary question
In Part I, how many participants experienced treatment-emergent adverse events and serious treatment-emergent adverse events? The broader study also assessed pharmacokinetic and pharmacodynamic measures and planned preliminary antitumor assessment in Part II.
3. Trial Design
The registry classifies this as a phase I, non-randomized, single-group study with no masking. It records an enrollment of 44 participants. The study status is completed. The recorded start date is 2016-07-05 and the primary completion date is 2020-08-26.
The study had two stages. Part I was a safety evaluation of two zanubrutinib regimens: 160 mg twice daily, administered in the morning and at night, or 320 mg once daily. The registry says a 3+3 design was adopted and that Part I results were used to determine the recommended Phase 2 dose and administration method. The operational details of the dose-escalation process and the dose-selection criteria are not reported in the registry record.
Part II was a dose-expansion stage using the recommended Phase 2 dose. It was intended to further evaluate preliminary antitumor effects in Chinese participants with follicular lymphoma or marginal zone lymphoma, with approximately 20 participants with relapsed or refractory disease planned. The arm record identifies this stage as 160 mg twice daily.
Because allocation was non-randomized and there was no masked control group, the regimen groups are not exchangeable comparison groups by design. They belong to different stages and may have different participant characteristics or study purposes. Their counts describe participants within the recorded groups; they do not establish that one schedule is safer or more effective than another.
The primary outcome is a Part I safety count. Secondary outcomes listed by the registry include single-dose measures of zanubrutinib exposure and steady-state exposure. The study record also identifies an antitumor assessment purpose for Part II, but does not report a comparative efficacy analysis.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Part I: 160 mg BID | Part I: 320 mg QD | Part II: 160 mg BID |
|---|---|---|---|
| STARTED | 11 | 10 | 23 |
| Received at Least 1 Dose of Study Drug | 11 | 10 | 23 |
| COMPLETED | 0 | 0 | 0 |
| NOT COMPLETED | 11 | 10 | 23 |
Reasons for not completing this period:
| Reason | Part I: 160 mg BID | Part I: 320 mg QD | Part II: 160 mg BID |
|---|---|---|---|
| Study terminated by Sponsor after final analysis and all remaining participants transferred to LTE | 7 | 5 | 11 |
| Death | 2 | 2 | 1 |
| Lost to Follow-up | 1 | 0 | 8 |
| Withdrawal by Subject | 1 | 1 | 3 |
| Progressive Disease | 0 | 2 | 0 |
Analysis population for the primary outcome, as defined in the registry: Safety Analysis Set: Included all participants who received ≥ 1 dose of zanubrutinib. The Safety Analysis Set was used for all summaries (except DLT and PK).
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Part I: 160 mg BID | Part I: 320 mg QD | Part II: 160 mg BID | Total |
|---|---|---|---|---|---|
| Participants analysed | 11 | 10 | 23 | 44 | |
| Age, Continuous | years | 51.9 (SD 10.65) | 52.1 (SD 10.57) | 48.4 (SD 11.85) | 50.1 (SD 11.18) |
| Sex: Female, Male: Female | Participants | 2 | 3 | 15 | 20 |
| Sex: Female, Male: Male | Participants | 9 | 7 | 8 | 24 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 11 | 10 | 23 | 44 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Part I: Number Of Participants Experiencing Treatment-emergent Adverse Events And Treatment-emergent Serious Adverse Events, measured over From the date of informed consent until 30 +/- 7 days after treatment discontinuation (up to 4 years and 1 month).
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The Part I primary endpoint counts participants experiencing treatment-emergent adverse events and treatment-emergent serious adverse events. It is a participant count, not a measure of how many separate episodes occurred or how long an event lasted. A participant may experience more than one adverse event, so a count of participants with an event does not describe the full event burden by itself.
The registry defines treatment-emergent events by timing: an event had to begin, or increase in severity, after the initial dose and within 30 days after the last dose or initiation of new anticancer therapy, whichever came sooner. The stated observation timeframe runs from informed consent until 30 +/- 7 days after treatment discontinuation, with a maximum stated duration of up to 4 years and 1 month.
A serious adverse event was defined by outcomes or required care, including death, a life-threatening event, hospitalization or prolonged hospitalization, disability or incapacity, a congenital anomaly or birth defect, or another significant medical event requiring intervention. Adverse events were assessed using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.03.
Counting participants with events is useful in an early-phase safety evaluation because it describes how many people had at least one event under the study's event definitions. It does not by itself establish causality, compare risks against an untreated group, or indicate the frequency of every event episode.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted adverse-event counts describe participants in the study's recorded regimen and stage groups. In Part I, serious adverse events were recorded for 2 of 11 participants in the 160 mg twice-daily group and 2 of 10 participants in the 320 mg once-daily group. Other adverse events were recorded for 11 of 11 and 10 of 10 participants, respectively. In Part II, serious adverse events were recorded for 5 of 23 participants, and other adverse events for 22 of 23 participants.
These are descriptive counts from a non-randomized study. Part I and Part II had different roles, and Part II followed dose selection in Part I. The registry does not describe randomized assignment to the regimens. Differences among the observed counts therefore cannot isolate a regimen effect from differences in participant mix, study stage, exposure, follow-up, or other factors. The record does not provide adjusted comparisons or uncertainty estimates for these counts.
The registry also records deaths by group: 2 in Part I at 160 mg twice daily, 3 in Part I at 320 mg once daily, and 1 in Part II at 160 mg twice daily. These are counts, not a statement that zanubrutinib caused the deaths. A cause-of-death breakdown or causal assessment for these deaths is not reported in the registry record.
Several serious-event terms are listed with percentages, including febrile neutropenia, neutrophil count decreased, and platelet count decreased at 10.0% each; cholesterin granuloma of middle ear and toxic epidermal necrolysis at 9.1% each; and anaemia at 4.3%. The record excerpt does not define the denominator or provide a group-specific breakdown for these listed term percentages, so they should be read as registry-listed percentages rather than recalculated or assigned to a particular regimen.
No p-values, confidence intervals, or formal comparative analyses are reported in the registry record. A confidence interval, in general, expresses the uncertainty around an estimated quantity under a specified statistical method; without one, the precision of a comparative effect cannot be assessed from these results. The registry lists no analysis records. The adverse-event counts therefore support a descriptive reading only, not a conclusion about comparative safety or treatment effect.
The listed secondary outcomes concern pharmacokinetics, including plasma concentration measures after single dosing and area under the curve at steady state. Their inclusion identifies what the study planned to assess; numerical outcome results for those measures are not reported in the registry record. Likewise, although Part II was intended to evaluate preliminary antitumor effects, an efficacy estimate is not reported in the registry record.
9. Statistical Methods Explained
The study's statistical interpretation starts with its design. It is recorded as non-randomized, unmasked, and single-group, while also describing dose groups and two stages. These descriptions are compatible with a study that evaluates more than one regimen without creating randomized comparison groups. Randomization is generally used to make treatment groups comparable, on average, with respect to measured and unmeasured factors. Without randomized allocation, observed group differences can reflect those factors as well as treatment schedules or study stage. This is why the group counts are descriptive rather than causal comparisons.
What does a participant count measure?
The primary endpoint counts participants with at least one treatment-emergent adverse event and participants with at least one serious treatment-emergent adverse event. A participant-level count answers how many people met the event definition. It does not count repeat events as additional affected participants, distinguish one event from several events in the same person, or convey event duration. Event counts and participant counts answer different questions. The registry identifies this primary measure as a count of participants.
The event definition is also important to interpretation. An event was treatment emergent if its onset, or an increase in its severity, occurred after the initial dose and within the specified post-treatment window or before new anticancer therapy, whichever came sooner. The serious-event definition uses clinical consequences and care requirements, including death, life-threatening events, hospitalization, disability, congenital anomaly or birth defect, and significant medical events requiring intervention. The registry says toxicity and adverse events were graded using NCI-CTCAE Version 4.03. These definitions govern what is counted; they do not by themselves establish that study drug caused an event.
Why does the study stage matter?
Part I evaluated two dosing regimens for safety and dose selection using a 3+3 design, according to the registry. Part II used the recommended Phase 2 dose for a dose expansion among participants with follicular lymphoma or marginal zone lymphoma. These stages had different purposes, and the Part II group was not a randomized counterpart to either Part I group. A direct numerical contrast across stages can therefore mix dose, disease group, selection, and stage effects. The protocol's detailed statistical methods for dose selection are not reported in the registry record.
In general, early-phase safety studies use descriptive summaries to characterize events and support dose evaluation. A count or proportion can be informative about what occurred among enrolled participants, but its precision depends on the number of participants and the event definition. Confidence intervals can communicate uncertainty around an estimated proportion, while a formal comparison requires a suitable design and analysis. Confidence intervals, comparative effect estimates, and p-values for the primary safety endpoint are not reported in the registry record.
What can pharmacokinetic measures tell readers?
The secondary outcomes include area under the plasma concentration-time curve through the last measurable concentration and to infinity, maximum plasma concentration, time to maximum concentration, apparent terminal half-life, apparent plasma clearance, terminal apparent volume of distribution, and area under the curve at steady state. In general, these measures describe drug exposure and the time course of measured concentrations. They address pharmacokinetic questions, not whether a clinical outcome is improved. The registry's listing of these outcomes does not supply numerical estimates; those results are not reported in the registry record.
The brief summary also states that the study investigated pharmacodynamics. In general, pharmacodynamic measures concern biological responses associated with a drug. Specific pharmacodynamic endpoints and their numerical results are not reported in the registry record. The planned preliminary antitumor assessment in Part II likewise does not constitute an efficacy result in the absence of posted outcome estimates.
How should planning calculations be understood?
In general, a sample-size calculation translates assumptions about a target effect, variability, significance level, allocation, and analysis method into a planning quantity. The record's planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a fraction of the observed effect. Those assumptions describe a planning illustration, not the trial's own design. The study itself is non-randomized and includes distinct stages and dose groups, rather than a two-arm randomized comparison with equal allocation.
A planning calculation based on an observed effect is conditional on that effect and the stated assumptions. It does not show the probability that the completed study detected an effect, and it should not be called observed power. The registry record does not report a protocol sample-size justification or the assumptions used to determine enrollment of 44 participants. No numerical planning result should be interpreted as an observed study outcome or as evidence that the actual design had a particular level of power.
For time-to-event outcomes, general planning methods may use total event counts because information is linked to events over follow-up. For other outcomes, a planning quantity may be expressed as participants per arm. These general distinctions do not establish that this trial had a time-to-event primary outcome: its primary endpoint is a participant count for adverse events. A detailed statistical analysis plan, including the handling of multiple outcomes and the inferential procedures used, is not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 18 outcome measures, including the Part I adverse-event endpoint and several pharmacokinetic measures. When many outcomes are assessed, the chance of at least one apparently unusual result can increase if each is tested separately. General approaches to this issue include defining a primary endpoint in advance, specifying a testing hierarchy, or adjusting for multiple comparisons. The multiplicity strategy for this study is not reported in the registry record. The listing of a primary endpoint does not reveal whether or how the secondary outcomes were incorporated into a formal testing plan.
Missing-data methods are not reported in the registry record. The record does not describe how participants with incomplete follow-up, missing measurements, or early treatment discontinuation were handled in analyses, nor does it report sensitivity analyses for missing data. This matters because the amount and timing of observation can affect the opportunity to record adverse events and pharmacokinetic measurements. The registry describes the safety observation timeframe, but that timeframe does not establish how incomplete observations were analyzed.
The primary outcome specifies a Safety Analysis Set consisting of participants who received at least 1 dose of zanubrutinib, used for all summaries except dose-limiting toxicity and pharmacokinetics. Further details about analysis populations, exclusions, and population-specific counts are not reported in the registry record. The record lists no analysis records, so formal tests and model-based estimates cannot be assessed from the posted results.
The registry does not report interim-analysis procedures, stopping boundaries, or a statistical analysis plan. It also does not report whether a multiplicity adjustment or a missing-data sensitivity analysis was performed. These items should not be inferred from the phase, the 3+3 design description, or the outcome list.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Part I: 160 mg BID | 2 | 11 | 18.2% |
| Part I: 320 mg QD | 2 | 10 | 20.0% |
| Part II: 160 mg BID | 5 | 23 | 21.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Part I: 160 mg BID | 2 of 11 |
| Part I: 320 mg QD | 3 of 10 |
| Part II: 160 mg BID | 1 of 23 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 3% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Part I: 160 mg BID | 11 of 11 |
| Part I: 320 mg QD | 10 of 10 |
| Part II: 160 mg BID | 22 of 23 |
Most frequent serious adverse event terms
| Event term | Organ system | Part I: 160 mg BID | Part I: 320 mg QD | Part II: 160 mg BID |
|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 0 of 11 | 0 of 10 | 1 of 23 |
| Febrile neutropenia | Blood and lymphatic system disorders | 0 of 11 | 1 of 10 | 0 of 23 |
| Lymphadenopathy | Blood and lymphatic system disorders | 0 of 11 | 0 of 10 | 1 of 23 |
| Neutrophil count decreased | Investigations | 0 of 11 | 1 of 10 | 0 of 23 |
| Platelet count decreased | Investigations | 0 of 11 | 1 of 10 | 0 of 23 |
| Ascites | Gastrointestinal disorders | 0 of 11 | 0 of 10 | 1 of 23 |
| Fatigue | General disorders | 0 of 11 | 0 of 10 | 1 of 23 |
| Pleural infection | Infections and infestations | 0 of 11 | 0 of 10 | 1 of 23 |
| Pneumonia | Infections and infestations | 0 of 11 | 0 of 10 | 1 of 23 |
| Hyperglycaemia | Metabolism and nutrition disorders | 0 of 11 | 0 of 10 | 1 of 23 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Part I: 160 mg BID | Part I: 320 mg QD | Part II: 160 mg BID |
|---|---|---|---|---|
| Neutrophil count decreased | Investigations | 8 of 11 | 7 of 10 | 9 of 23 |
| Anaemia | Blood and lymphatic system disorders | 4 of 11 | 4 of 10 | 8 of 23 |
| White blood cell count decreased | Investigations | 3 of 11 | 3 of 10 | 9 of 23 |
| Upper respiratory tract infection | Infections and infestations | 5 of 11 | 5 of 10 | 5 of 23 |
| Platelet count decreased | Investigations | 4 of 11 | 2 of 10 | 4 of 23 |
| Rash | Skin and subcutaneous tissue disorders | 3 of 11 | 2 of 10 | 5 of 23 |
| Hyperuricaemia | Metabolism and nutrition disorders | 2 of 11 | 3 of 10 | 5 of 23 |
| Pneumonia | Infections and infestations | 3 of 11 | 3 of 10 | 3 of 23 |
| Haematuria | Renal and urinary disorders | 4 of 11 | 3 of 10 | 2 of 23 |
| Weight increased | Investigations | 2 of 11 | 3 of 10 | 3 of 23 |
Serious events with the highest arm-level rate: febrile neutropenia (10.0%), neutrophil count decreased (10.0%), platelet count decreased (10.0%), cholesterin granuloma of middle ear (9.1%), toxic epidermal necrolysis (9.1%).
For Part I, the registry records serious adverse events in 2 of 11 participants receiving 160 mg twice daily and 2 of 10 receiving 320 mg once daily. The corresponding counts for other adverse events are 11 of 11 and 10 of 10. For Part II at 160 mg twice daily, serious adverse events were recorded in 5 of 23 participants and other adverse events in 22 of 23. These figures describe the groups as recorded; they do not establish a causal relationship to zanubrutinib.
Serious adverse events are defined by specified consequences or care requirements, not simply by symptom intensity. The registry states that event summaries include serious and other non-serious adverse events regardless of causality. This means the counts should not be read as counts of events judged drug-related. The record's definition of treatment emergence depends on event timing, while seriousness follows the stated outcome and care criteria.
The death counts are 2, 3, and 1 across the three listed groups, respectively. The registry record does not report causes for these deaths in the material summarized by these counts, so they cannot be attributed to treatment from the counts alone. The listed serious-event terms and percentages also lack a stated denominator and group-specific attribution in the registry record. Interpret them as descriptive listings, not as comparative rates.
12. What the Result Does, and Does Not, Mean
The results describe safety events observed among participants in a phase I study of zanubrutinib in Chinese participants with B-cell lymphoma. The record reports participant counts for serious and other adverse events in three regimen-stage groups, along with death counts and a list of serious-event terms with percentages. These observations provide a descriptive account within the registry's stated event definitions and safety population.
They do not establish that zanubrutinib caused any individual event or death. The registry says adverse-event summaries include events regardless of causality, and the group counts alone do not provide a causal assessment. Nor do these data establish that one dosing schedule is safer than another. The study was non-randomized, the groups were part of different stages, and no like-for-like randomized control comparison is described.
The record's goal also included pharmacokinetic and pharmacodynamic investigation and preliminary antitumor assessment in Part II. However, numerical results for the listed pharmacokinetic outcomes and an inferential antitumor estimate are not reported in the registry record. The study's stated objectives should not be mistaken for evidence that a particular clinical benefit was demonstrated.
Precision cannot be characterized fully from the posted counts because confidence intervals and comparative estimates are not reported in the registry record. In general, counts from a limited study population can be sensitive to individual observations, and the absence of an appropriate control group limits comparative conclusions regardless of how clearly the counts are presented. These data are most appropriately read as descriptive findings from the participants and follow-up recorded, not as a definitive comparison of regimens or a broad estimate for all people with B-cell lymphoma.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of how early-phase objectives shape the questions that can be answered. Part I was designed around safety evaluation and dose selection, while Part II was intended to expand assessment at the recommended Phase 2 dose. The registry describes both schedules and stages, but its non-randomized design does not support treating the groups as comparable arms of a controlled trial.
That distinction matters when reading observed counts. Counts can accurately describe what was recorded in each group without explaining why the groups differ. In a staged study, group membership is linked to study purpose and dose selection, and there is no randomized allocation to balance other participant characteristics. A descriptive safety summary is therefore not the same as a comparative estimate of treatment effect.
The study also separates several types of scientific questions. Adverse-event counts concern participant safety observations; pharmacokinetic measures describe drug concentration and exposure; pharmacodynamic measures concern biological response; and the planned Part II assessment concerned preliminary antitumor effects. These outcomes are not interchangeable. Listing an outcome as planned does not mean a numerical result or an inferential conclusion is available.
Finally, the registry record illustrates the importance of transparent analysis details. The primary safety population and event definitions are described, but multiplicity handling, missing-data methods, interim procedures, and a detailed statistical analysis plan are not reported in the registry record. Those details are necessary for understanding how observed data were turned into formal estimates or tests. Where only descriptive counts are available, interpretation should remain descriptive.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation for interpretation is the non-randomized design. Although the registry identifies dose groups, it does not describe randomized allocation or a control group. Part I and Part II also serve different study purposes. Consequently, differences in event counts across these groups cannot be isolated as effects of dose or schedule.
The record reports adverse-event participant counts but does not provide confidence intervals, comparative estimates, or p-values for the primary safety endpoint. It also lists deaths without a cause-of-death breakdown in the summarized information. The serious-event term percentages are not accompanied by a stated denominator or group-specific breakdown in the registry record, limiting their interpretation as rates or comparisons.
The safety observation window is described, but the record does not report how incomplete follow-up or missing data were handled. It identifies the Safety Analysis Set as participants who received at least 1 dose, but detailed participant flow, exclusions, and analysis-population counts beyond the recorded group counts are not reported in the registry record.
Although pharmacokinetic outcomes and preliminary antitumor assessment are part of the study objectives, numerical results for those outcomes are not reported in the registry record. The protocol's sample-size justification, detailed statistical analysis plan, multiplicity approach, and interim-analysis methods are also not reported. These omissions prevent an assessment of the precision and inferential framework beyond the descriptive safety information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study to Investigate Zanubrutinib in Chinese Participants With B-cell Lymphoma — NCT03189524.
- Registry record last updated 2024-12-27; status last verified 2021-09.
- Results first posted 2021-10-22.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT03189524 is a completed phase I study sponsored by BeiGene, recorded as starting on 2016-07-05 and reaching primary completion on 2020-08-26. It enrolled 44 Chinese participants with B-cell lymphoma and evaluated zanubrutinib in a Part I safety and dose-evaluation stage followed by a Part II dose-expansion stage.
The registry describes non-randomized allocation, no masking, and a single-group model. Part I evaluated 160 mg twice daily and 320 mg once daily; Part II used the recommended Phase 2 dose and is identified in the arm record as 160 mg twice daily. The primary endpoint counted participants experiencing treatment-emergent adverse events and serious treatment-emergent adverse events in Part I. The Safety Analysis Set included participants who received at least 1 dose.
Posted safety information includes group-specific participant counts for serious and other adverse events and deaths. Numerical pharmacokinetic results, an inferential antitumor result, and formal analysis results are not reported in the registry record.