Comparison · NCT04745832-sae
Rituximab Plus Zandelisib vs Rituximab Plus Chemotherapy: 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. Rituximab Plus Zandelisib vs Rituximab Plus Chemotherapy: serious adverse events. Trial comparisons, record NCT04745832-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04745832-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 | 0.293 | 0.176 | 0.445 | wilson | |
| Risk in group 2 | 0.195 | 0.102 | 0.34 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0976 | -0.0885 | 0.276 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.5 | 0.686 | 3.28 | log | |
| Odds ratio, group 1 over group 2 | 1.71 | 0.613 | 4.75 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Rituximab Plus Zandelisib than on Rituximab Plus Chemotherapy | 10.3 | 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 | Rituximab Plus Zandelisib | Rituximab plus Zandelisib for 6 cycles followed by Zandelisib for 20 cycles Zandelisib: Zandelisib 60 mg capsules taken daily for two cycles followed by intermittent schedule starting at Cycle 3 Rituximab: Rituximab IV 375 mg/m2 for 6 cycles~In the Rituximab plus Zandelisib arm, 41 subjects enrolled | 12 | 41 | EG000 |
| Group 2 | Rituximab Plus Chemotherapy | Rituximab and Bendamustine or Rituximab with (CHOP) for 6 cycles Rituximab: Rituximab IV 375 mg/m2 for 6 cycles Bendamustine: Bendamustine IV 90 mg/m2 on Days 1 and 2 for 6 cycles CHOP: Cyclophosphamide, Vindcristine IV, and Prednisone daily orally~In the R-chemo arm 31 subjects were enrolled to R-B and 10 to R=CHOP | 8 | 41 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- The occurrence of adverse events was assessed for 1 year, 7 months
Source ClinicalTrials.gov
Trial
- Title
- Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)
- NCT number
- NCT04745832
- Phases
- PHASE3
- Conditions
- Follicular Lymphoma (FL), Non Hodgkin Lymphoma, Marginal Zone Lymphoma
- Interventions
- Zandelisib, Rituximab, Bendamustine, CHOP
- Lead sponsor
- MEI Pharma, Inc.
- Results first posted
- 2023-12-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04745832?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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