Comparison · NCT02285062-sae
Lenalidomide Plus R-CHOP (R2-CHOP) vs Placebo Plus 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. Lenalidomide Plus R-CHOP (R2-CHOP) vs Placebo Plus R-CHOP: serious adverse events. Trial comparisons, record NCT02285062-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02285062-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 | 0.367 | 0.313 | 0.425 | wilson | |
| Risk in group 2 | 0.31 | 0.259 | 0.366 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0576 | -0.0202 | 0.135 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.19 | 0.941 | 1.49 | log | |
| Odds ratio, group 1 over group 2 | 1.29 | 0.913 | 1.83 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Lenalidomide Plus R-CHOP (R2-CHOP) than on Placebo Plus R-CHOP | 17.4 | 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 | Lenalidomide Plus R-CHOP (R2-CHOP) | Participants received lenalidomide 15 mg capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m\^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m\^2 IV on Day 1, vincristine 1.4 mg/m\^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m\^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 cycles. Treatment continued until completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, whichever occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice. | 104 | 283 | EG000 |
| Group 2 | Placebo Plus R-CHOP | Participants received identically matching placebo capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m\^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m\^2 IV on Day 1, vincristine 1.4 mg/m\^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m\^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 to 8 cycles. Treatment continued until 6-8 cycles were completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice. | 88 | 284 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 86 months). SAEs and Other AEs were monitored from the participant's first dose of study treatment up to 28 days after their last dose of LEN/PBO or any component of R-CHOP including the optional 2 additional doses of rituximab; measured up to approximately 33 weeks.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety Study of Lenalidomide Plus R-CHOP Chemotherapy Versus Placebo Plus R-CHOP Chemotherapy in Untreated ABC Type Diffuse Large B-cell Lymphoma
- NCT number
- NCT02285062
- Phases
- PHASE3
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Interventions
- lenalidomide, Placebo, Rituximab, Cyclophosphamide, Doxorubicin, prednisone, vincristine
- Lead sponsor
- Celgene
- Results first posted
- 2020-03-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02285062?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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GET https://conductscience.org/api/comparisons/v1/NCT02285062-sae