Comparison · NCT04551963-sae
Arm A: Zanubrutinib With or Without Moderate CYP3A vs Arm B: Zanubrutinib With or Without Strong CYP3A: 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: Zanubrutinib With or Without Moderate CYP3A vs Arm B: Zanubrutinib With or Without Strong CYP3A: serious adverse events. Trial comparisons, record NCT04551963-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04551963-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 | 0.231 | 0.0818 | 0.503 | wilson | |
| Risk in group 2 | 0.0769 | 0.0137 | 0.333 | wilson | |
| Risk difference, group 1 minus group 2 | 0.154 | -0.143 | 0.433 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3 | 0.357 | 25.2 | log | |
| Odds ratio, group 1 over group 2 | 3.6 | 0.322 | 40.2 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm A: Zanubrutinib With or Without Moderate CYP3A than on Arm B: Zanubrutinib With or Without Strong CYP3A | 6.5 | 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: Zanubrutinib With or Without Moderate CYP3A | Cycle 1 (30 days): Participants were administered zanubrutinib at a dose of 320 mg once a day from Day 1 to Day 3; From Day 4 to Day 10, fluconazole was administered once a day at a dose of 400 mg with zanubrutinib at a reduced dose of 80 mg twice a day; On Day 11 and Day 12, zanubrutinib monotherapy was administered at 80 mg twice a day, followed by 320 mg once a day from Day 13 to Day 21; From Day 22 to Day 28, diltiazem was administered once a day at a dose of 180 mg with 80 mg zanubrutinib twice a day; On Day 29 and Day 30, zanubrutinib monotherapy was administered 80 mg twice a day.~Cycles 2 to 6 (28 days each cycle): Zanubrutinib 160 mg twice a day or 320 mg once a day. | 3 | 13 | EG000 |
| Group 2 | Arm B: Zanubrutinib With or Without Strong CYP3A | Cycle 1 (30 days): Participants were administered zanubrutinib at a dose of 320 mg once a day from Day 1 to Day 3; From Day 4 to Day 10, voriconazole was administered twice a day at a dose of 200 mg (total daily dose of 400 mg) with zanubrutinib at a reduced dose of 80 mg once a day; On Day 11 and Day 12, zanubrutinib monotherapy was administered at 80 mg once a day, followed by 320 mg once a day from Day 13 to Day 21; From Day 22 to Day 28, clarithromycin was administered twice a day at a dose of 250 mg (total daily dose of 500 mg) with 80 mg zanubrutinib once a day; On Day 29 and Day 30, zanubrutinib monotherapy was administered 80 mg once a day.~Cycles 2 to 6 (28 days each cycle): Zanubrutinib 160 mg twice a day or 320 mg once a day. | 1 | 13 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the date of first study drug administration to 30 days after last dose (up to approximately 15 months)
Source ClinicalTrials.gov
Trial
- Title
- Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Participants With B-Cell Malignancies
- NCT number
- NCT04551963
- Phases
- PHASE1
- Conditions
- B-cell Malignancies
- Interventions
- Zanubrutinib, Fluconazole, Diltiazem, Voriconazole, Clarithromycin
- Lead sponsor
- BeiGene
- Results first posted
- 2023-11-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04551963?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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