Comparison · NCT04933617-sae
Dose Escalation: Arm 1, Dose Level 1, Original: 30mg Copanlisib vs Dose Escalation: Arm 1, Dose Level 1, Modified: 30mg Copanlisib: 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. Dose Escalation: Arm 1, Dose Level 1, Original: 30mg Copanlisib vs Dose Escalation: Arm 1, Dose Level 1, Modified: 30mg Copanlisib: serious adverse events. Trial comparisons, record NCT04933617-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04933617-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 | 0.4 | 0.118 | 0.769 | wilson | |
| Risk in group 2 | 0 | 0.0000000000000000555 | 0.561 | wilson | |
| Risk difference, group 1 minus group 2 | 0.4 | -0.229 | 0.769 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
Number needed to harm, for one more participant with a serious adverse event on Dose Escalation: Arm 1, Dose Level 1, Original: 30mg Copanlisib than on Dose Escalation: Arm 1, Dose Level 1, Modified: 30mg Copanlisib | 2.5 | 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 | Dose Escalation: Arm 1, Dose Level 1, Original: 30mg Copanlisib | Copanlisib intravenous (IV) per dose level (30 mg) on days 1 and 5 of each 21-day cycle in combination with standard dosing dose adjusted rituximab, etoposide, prednisolone, vincristine, cyclophosphamide, doxorubicin (DA-EPOCH-R) to determine recommended phase 2 dose (RP2D) and maximum tolerated dose (MTD) of copanlisib. Up to 6 cycles total.~Rituximab: Rituximab 375 mg/m\^2 intravenous (IV) per protocol on Day 1 of each cycle up to 6 cycles~Etoposide: Etoposide 50 mg/m\^2/day continuous intravenous infusion (CIVI) on Days 1-4 of each cycle up to 6 cycles~Copanlisib: Copanlisib intravenous (IV) is administered at a fixed dose (30 mg) on days 1 and 5 of each 21-day cycle for up to 6 cycles.~Cyclophosphamide: Cyclophosphamide 750 mg/m\^2 intravenous (IV) on Day 5 of each cycle up to 6 cycles~Doxorubicin: Doxorubicin 10 mg/m\^2/day continuous intravenous infusion (CIVI) on Days 1-4 of each cycle up to 6 cycles~Vincristine: Vincristine 0.4 mg/m\^2/day (no cap) continuous intravenous infusion (CIVI) on Days 1-4 of each cycle up to 6 cycles~Prednisone: Prednisone 60 mg/m\^2 by mouth (PO) twice a day (BID) Days 1-5 (total 120mg/m\^2/day) | 2 | 5 | EG000 |
| Group 2 | Dose Escalation: Arm 1, Dose Level 1, Modified: 30mg Copanlisib | Copanlisib intravenous (IV) per dose level (30 mg) on day 1 of each 21-day cycle in combination with standard dosing dose adjusted rituximab, etoposide, prednisolone, vincristine, cyclophosphamide, doxorubicin (DA-EPOCH-R) to determine recommended phase 2 dose (RP2D) and maximum tolerated dose (MTD) of copanlisib. Up to 6 cycles total.~Rituximab: Rituximab 375 mg/m\^2 intravenous (IV) per protocol on Day 1 of each cycle up to 6 cycles~Etoposide: Etoposide 50 mg/m\^2/day continuous intravenous infusion (CIVI) on Days 1-4 of each cycle up to 6 cycles~Copanlisib: Copanlisib intravenous (IV) is administered at a fixed dose (30 mg) on day 1 of each 21-day cycle for up to 6 cycles.~Cyclophosphamide: Cyclophosphamide 750 mg/m\^2 intravenous (IV) on Day 5 of each cycle up to 6 cycles~Doxorubicin: Doxorubicin 10 mg/m\^2/day continuous intravenous infusion (CIVI) on Days 1-4 of each cycle up to 6 cycles~Vincristine: Vincristine 0.4 mg/m\^2/day (no cap) continuous intravenous infusion (CIVI) on Days 1-4 of each cycle up to 6 cycles~Prednisone: Prednisone 60 mg/m\^2 by mouth (PO) twice a day (BID) Days 1-5 (total 120mg/m\^2/day) | 0 | 3 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Date treatment consent signed to date off study, an average of 245.5 days.
Source ClinicalTrials.gov
Trial
- Title
- Copanlisib With Dose-Adjusted EPOCH-R in Relapsed and Refractory Burkitt Lymphoma and Other High-Grade B-cell Lymphomas
- NCT number
- NCT04933617
- Phases
- PHASE1
- Conditions
- Burkitt Lymphoma, High-grade B-cell Lymphoma, T-cell/Histocyte-rich Large B-cell Lymphoma, Diffuse Large B-Cell Lymphoma (DLBCL), Germinal Center B-cell Type (GCB)
- Interventions
- Rituximab, Etoposide, Copanlisib, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, ECHO, EKG, MRI Brain, 18F-FDG - PET, CT Scan, Bone Marrow Aspiration, Bone Marrow Biopsy, Lumbar Puncture (LP)
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2024-07-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04933617?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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