Comparison · NCT04236141-sae
Polatuzumab Vedotin Plus Bendamustine and Rituximab vs Placebo Plus Bendamustine and Rituximab: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Polatuzumab Vedotin Plus Bendamustine and Rituximab vs Placebo Plus Bendamustine and Rituximab: serious adverse events. Trial comparisons, record NCT04236141-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04236141-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 | 0.444 | 0.276 | 0.627 | wilson | |
| Risk in group 2 | 0.214 | 0.0757 | 0.476 | wilson | |
| Risk difference, group 1 minus group 2 | 0.23 | -0.0811 | 0.459 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.07 | 0.699 | 6.16 | log | |
| Odds ratio, group 1 over group 2 | 2.93 | 0.664 | 13 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Polatuzumab Vedotin Plus Bendamustine and Rituximab than on Placebo Plus Bendamustine and Rituximab | 4.34 | 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 | Polatuzumab Vedotin Plus Bendamustine and Rituximab | Participants received polatuzumab vedotin administered at an initial dose of 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m\^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with polatuzumab vedotin. Each cycle is 21 days | 12 | 27 | EG000 |
| Group 2 | Placebo Plus Bendamustine and Rituximab | Participants received polatuzumab vedotin matching placebo by IV infusion on Day 2 of Cycle 1 and thereafter on Day 1 of Cycles 2-6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion, on Days 2 and 3 of Cycle 1 and thereafter on Days 1 and 2 of Cycles 2-6 and rituximab, 375 mg/m\^2, as IV infusion, at least 30 minutes before the administration of other study treatments, on Day 1 of Cycles 1-6, concurrently with placebo. Each cycle is 21 days. | 3 | 14 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to approximately 82 weeks
Source ClinicalTrials.gov
Trial
- Title
A Study to Evaluate the Efficacy and Safety of Polatuzumab Vedotin in Combination With Bendamustine and Rituximab Compared With Bendamustine and Rituximab Alone in Chinese Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL).
- NCT number
- NCT04236141
- Phases
- PHASE3
- Conditions
- Diffuse, Large B-Cell, Lymphoma
- Interventions
- Polatuzumab Vedotin, Bendamustine, Rituximab, Placebo
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2022-08-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04236141?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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