Comparison · NCT04182204-666db7c6
Stage 1: Pola-R-GemOx vs Stage 2: Pola-R-GemOx: Stage 1 and Stage 2: Number of Participants With Dose Modification for Polatuzumab Vedotin
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. Stage 1: Pola-R-GemOx vs Stage 2: Pola-R-GemOx: Stage 1 and Stage 2: Number of Participants With Dose Modification for Polatuzumab Vedotin. Trial comparisons, record NCT04182204-666db7c6. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04182204-666db7c6
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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 | 0.2 | 0.0705 | 0.452 | wilson | |
| Risk in group 2 | 0.172 | 0.116 | 0.247 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0281 | -0.121 | 0.286 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.16 | 0.395 | 3.43 | log | |
| Odds ratio, group 1 over group 2 | 1.2 | 0.314 | 4.63 | log | |
| Number needed to treat, for one more participant with the outcome on Stage 1: Pola-R-GemOx than on Stage 2: Pola-R-GemOx | 35.6 | 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 | Stage 1: Pola-R-GemOx | Participants received rituximab, 375 mg/m\^2, IV, followed by polatuzumab vedotin, 1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\^2, IV followed by oxaliplatin 100 mg/m\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles. | 3 | 15 | OG000 |
| Group 2 | Stage 2: Pola-R-GemOx | Participants received rituximab, 375 mg/m\^2, IV, followed by polatuzumab vedotin,1.8 mg/kg, IV on Day 1 of each 21-day cycle. Participants also received gemcitabine, 1000 mg/m\^2, IV followed by oxaliplatin 100 mg/m\^2, IV on Day 2 of each 21-day cycle for up to 8 cycles. | 22 | 128 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Stage 1 and Stage 2: Number of Participants With Dose Modification for Polatuzumab Vedotin
- Description
Dose modifications (interruptions/reductions) were based on physical examination findings, observed toxicities, and laboratory results obtained within 72 hours before study treatment administration. The determination of all dose modifications was made based on the investigator's assessment of ongoing clinical benefit with continuing study treatment. Dosing occurred only when a participant's clinical assessment and laboratory test values were acceptable.
- Time frame
- Stage 1: Up to approximately 5.3 months and Stage 2: Up to approximately 7.6 months
- Population
- Safety population included all participants who received any amount of any study drug (regardless of the stage).
Source ClinicalTrials.gov
Trial
- Title
A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
- NCT number
- NCT04182204
- Phases
- PHASE3
- Conditions
- Diffuse Large B-Cell Lymphoma
- Interventions
- Polatuzumab Vedotin, Rituximab, Gemcitabine, Oxaliplatin
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2025-12-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04182204?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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