Comparison · NCT01974440-6e04fc30
Placebo + Chemoimmunotherapy (CIT) vs Ibrutinib + CIT: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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: Number of Participants With Treatment-emergent Adverse Events (TEAEs). Trial comparisons, record NCT01974440-6e04fc30. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01974440-6e04fc30
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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 | 0.99 | 0.964 | 0.997 | wilson | |
| Risk in group 2 | 0.99 | 0.964 | 0.997 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0001 | -0.0269 | 0.0265 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.98 | 1.02 | log | |
| Odds ratio, group 1 over group 2 | 0.99 | 0.138 | 7.1 | log | |
| Number needed to treat, for one fewer participant with the outcome on Placebo + Chemoimmunotherapy (CIT) than on Ibrutinib + CIT | 10,000 | 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 | 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. | 197 | 199 | OG000 |
| 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. | 199 | 201 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
- Description
Number of participants with TEAEs were reported. Adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as adverse events with onset or worsening on or after date of first dose of study treatment up to and including 30 days after date of last dose of study medication.
- Time frame
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 date of last dose of study medication (up to 8 years 8 months)
- Population
- Safety analysis population included all randomized participants who received at least 1 dose of study drug, and were analyzed according to the actual treatment received.
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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