Comparison · NCT04665765-sae
Safety Lead-In vs Phase II: 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. Safety Lead-In vs Phase II: serious adverse events. Trial comparisons, record NCT04665765-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04665765-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 | 0.167 | 0.0301 | 0.564 | wilson | |
| Risk in group 2 | 0.229 | 0.121 | 0.39 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0619 | -0.274 | 0.349 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.729 | 0.11 | 4.83 | log | |
| Odds ratio, group 1 over group 2 | 0.675 | 0.0685 | 6.65 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Safety Lead-In than on Phase II | 16.2 | 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 | Safety Lead-In | SALVAGE THERAPY: Patients receive polatuzumab vedotin IV on day 1, rituximab IV on day 1, etoposide IV on days 1-3, carboplatin IV on day 2, and ifosfamide IV on day 2 or days 1-3. Treatment repeats every 21 days for up to 2-3 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response, partial response or stable disease by C2D15 may receive 1 additional cycle of PolaR-ICE IV.~CONSOLIDATION THERAPY: Within 30-60 days after ASCT, patients receive polatuzumab vedotin IV on day 1. Treatment repeats every 21 days for up to 3-4 cycles in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Polatuzumab Vedotin: Given IV~Rituximab: Given IV | 1 | 6 | EG000 |
| Group 2 | Phase II | SALVAGE THERAPY: Patients receive polatuzumab vedotin IV on day 1, rituximab IV on day 1, etoposide IV on days 1-3, carboplatin IV on day 2, and ifosfamide IV on day 2 or days 1-3. Treatment repeats every 21 days for up to 2-3 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response, partial response or stable disease by C2D15 may receive 1 additional cycle of PolaR-ICE IV.~CONSOLIDATION THERAPY: Within 30-60 days after ASCT, patients receive polatuzumab vedotin IV on day 1. Treatment repeats every 21 days for up to 3-4 cycles in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Etoposide: Given IV~Ifosfamide: Given IV~Polatuzumab Vedotin: Given IV~Rituximab: Given IV | 8 | 35 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Averse events were assessed from the initial treatment to 30 days after the end of the treatment. Participants received three 21-day cycles of PolaR-ICE for salvage therapy and up to four 21-day cycles of Pola for consolidation therapy. Adverse events were monitored and assessed at each cycle treatment. Vital status was assessed from the initial treatment up to 2 years after the end of the treatment.
Source ClinicalTrials.gov
Trial
- Title
- Polatuzumab Vedotin, Rituximab, Ifosfamide, Carboplatin, and Etoposide (PolaR-ICE) as Initial Salvage Therapy for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
- NCT number
- NCT04665765
- Phases
- PHASE2
- Conditions
Diffuse Large B-Cell Lymphoma Unclassifiable, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma, Recurrent Transformed B-Cell Non-Hodgkin Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Refractory Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma, Refractory Transformed B-Cell Non-Hodgkin Lymphoma
- Interventions
- Carboplatin, Etoposide, Ifosfamide, Polatuzumab Vedotin, Rituximab
- Lead sponsor
- City of Hope Medical Center
- Results first posted
- 2024-08-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04665765?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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