Comparison · NCT03053440-sae
Arm A: Ibrutinib vs Arm B: Zanubrutinib: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Arm A: Ibrutinib vs Arm B: Zanubrutinib: serious adverse events. Trial comparisons, record NCT03053440-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03053440-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.51 | 0.413 | 0.607 | wilson | |
| Risk in group 2 | 0.584 | 0.487 | 0.675 | wilson | |
| Risk difference, group 1 minus group 2 | -0.074 | -0.208 | 0.0634 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.873 | 0.677 | 1.13 | log | |
| Odds ratio, group 1 over group 2 | 0.742 | 0.424 | 1.3 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm A: Ibrutinib than on Arm B: Zanubrutinib | 13.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 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 | 50 | 98 | EG000 |
| Group 2 | 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 | 59 | 101 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- up to approximately 5 years and 5 months
Source ClinicalTrials.gov
Trial
- Title
- A Study Comparing BGB-3111 and Ibrutinib in Participants With Waldenström's Macroglobulinemia (WM)
- NCT number
- NCT03053440
- Phases
- PHASE3
- Conditions
- Waldenström's Macroglobulinemia
- Interventions
- BGB-3111, Ibrutinib
- Lead sponsor
- BeiGene
- Results first posted
- 2023-06-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03053440?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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