Comparison · NCT01855750-sae
Treatment Arm B: Ibrutinib+R-CHOP vs Treatment Arm A: Placebo+R-CHOP: 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. Treatment Arm B: Ibrutinib+R-CHOP vs Treatment Arm A: Placebo+R-CHOP: serious adverse events. Trial comparisons, record NCT01855750-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01855750-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 | 0.531 | 0.483 | 0.579 | wilson | |
| Risk in group 2 | 0.342 | 0.298 | 0.389 | wilson | |
| Risk difference, group 1 minus group 2 | 0.189 | 0.122 | 0.254 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.55 | 1.32 | 1.82 | log | |
| Odds ratio, group 1 over group 2 | 2.18 | 1.65 | 2.88 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Treatment Arm B: Ibrutinib+R-CHOP than on Treatment Arm A: Placebo+R-CHOP | 5.29 | 3.94 | 8.19 | from the risk difference interval |
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 | Treatment Arm B: Ibrutinib+R-CHOP | Participants received ibrutinib 560 milligram (mg) (4\*140 mg) capsules orally once daily (Cycle 1 Day 1 to Day 21 of last cycle; 21-day cycles) along with R-CHOP (Rituximab - Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) as a background chemotherapy. R-CHOP regimen included rituximab 375 milligram per square meter (mg/m\^2) intravenously (IV), cyclophosphamide 750 mg/m\^2 IV, doxorubicin 50 mg/m\^2 IV, and vincristine 1.4 mg/m\^2 IV, administered on Day 1 and prednisone 100 mg capsules orally on Days 1 to 5 of each cycle. Participants received background chemotherapy plus ibrutinib for 6 or 8 cycles per site preference (21 days per cycle). | 221 | 416 | EG000 |
| Group 2 | Treatment Arm A: Placebo+R-CHOP | Participants received matching placebo (4 capsules) orally once daily (21-day cycles) along with R-CHOP background chemotherapy. R-CHOP regimen included rituximab 375 milligram per square meter (mg/m\^2) intravenously (IV), cyclophosphamide 750 mg/m\^2 IV, doxorubicin 50 mg/m\^2 IV, and vincristine 1.4 mg/m\^2 IV, administered on Day 1 and prednisone 100 mg capsules orally on Days 1 to 5 of each cycle. Participants received background chemotherapy plus matching placebo for 6 or 8 cycles per site preference (21 days per cycle). | 143 | 418 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 5.5 years
Source ClinicalTrials.gov
Trial
- Title
A Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma
- NCT number
- NCT01855750
- Phases
- PHASE3
- Conditions
- Lymphoma
- Interventions
- Ibrutinib, Placebo, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (or equivalent)
- Lead sponsor
- Janssen Research & Development, LLC
- Results first posted
- 2019-03-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01855750?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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