Comparison · NCT01974440-sae
Placebo + Chemoimmunotherapy (CIT) vs Ibrutinib + CIT: 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. Placebo + Chemoimmunotherapy (CIT) vs Ibrutinib + CIT: serious adverse events. Trial comparisons, record NCT01974440-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01974440-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 | 0.382 | 0.317 | 0.451 | wilson | |
| Risk in group 2 | 0.562 | 0.493 | 0.629 | wilson | |
| Risk difference, group 1 minus group 2 | -0.18 | -0.273 | -0.0825 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.679 | 0.548 | 0.842 | log | |
| Odds ratio, group 1 over group 2 | 0.481 | 0.323 | 0.717 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Placebo + Chemoimmunotherapy (CIT) than on Ibrutinib + CIT | 5.55 | 3.66 | 12.1 | 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 | Placebo + Chemoimmunotherapy (CIT) | Participants received 4 capsules of placebo matching to ibrutinib orally once daily continuously starting on Cycle 1, Day 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a background therapy for maximum of 6 cycles (each cycle = 21 days) either with BR: bendamustine hydrochloride 90 milligrams per meter square (mg/m\^2) intravenously (IV) on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV on Day 1 of each cycle; or background therapy with R-CHOP: rituximab 375 mg/m\^2 IV on Day 1, cyclophosphamide 750 mg/m\^2 IV on Day 1, doxorubicin 50 mg/m\^2 IV on Day 1, vincristine 1.4 mg/m\^2 IV (maximum total 2 mg) on Day 1, and prednisone 100 mg orally on Days 1 to 5 until disease progression or unacceptable toxicity. After treatment unblinding at the time of the primary analysis, participants randomized to arm Placebo + CIT discontinued placebo treatment. | 76 | 199 | EG000 |
| Group 2 | Ibrutinib + CIT | Participants received ibrutinib 560 mg capsules (4 capsules of 140 mg) orally once daily continuously starting on Cycle 1, Day 1 until disease progression, or unacceptable toxicity, or study end, whichever occurred first. All participants also received a background therapy for maximum of 6 cycles (each cycle = 21 days) either with BR: bendamustine hydrochloride 90 mg/m\^2 IV on Days 1 and 2 of each cycle and rituximab 375 mg/m\^2 IV on Day 1 of each cycle; or background therapy with R-CHOP: rituximab 375 mg/m\^2 IV on Day 1, cyclophosphamide 750 mg/m\^2 IV on Day 1, doxorubicin 50 mg/m\^2 IV on Day 1, vincristine 1.4 mg/m\^2 IV (maximum total 2 mg) on Day 1, and prednisone 100 mg orally on Days 1 to 5 until disease progression or unacceptable toxicity. After treatment unblinding at the time of the primary analysis, participants randomized to arm Ibrutinib + CIT continued/stopped treatment with ibrutinib at the discretion of the treating physician. | 113 | 201 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All Serious AEs and Other (Not Including Serious) AEs: for Placebo + Chemoimmunotherapy (CIT) arm: From Day 1 up to 30 days after date of last dose of study medication (up to 8 years); Ibrutinib + CIT arm: From Day 1 up to 30 days after last dose of study medication (up to 8 years 8 months); all cause mortality: From Day 1 up to end of study (up to 9 years 1 month)
Source ClinicalTrials.gov
Trial
- Title
A Study of PCI-32765 (Ibrutinib) in Combination With Either Bendamustine and Rituximab or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Participants With Previously Treated Indolent Non-Hodgkin Lymphoma
- NCT number
- NCT01974440
- Phases
- PHASE3
- Conditions
- Lymphoma
- Interventions
- Bendamustine, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, PCI-32765 (Ibrutinib), Placebo
- Lead sponsor
- Janssen Research & Development, LLC
- Results first posted
- 2023-04-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01974440?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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