Comparison · NCT02947347-sae
Arm A: Ibrutinib + Rituximab vs Arm B: Placebo + Rituximab: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Arm A: Ibrutinib + Rituximab vs Arm B: Placebo + Rituximab: serious adverse events. Trial comparisons, record NCT02947347-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02947347-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 | 0.641 | 0.588 | 0.69 | wilson | |
| Risk in group 2 | 0.432 | 0.344 | 0.525 | wilson | |
| Risk difference, group 1 minus group 2 | 0.208 | 0.101 | 0.31 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.48 | 1.18 | 1.86 | log | |
| Odds ratio, group 1 over group 2 | 2.34 | 1.51 | 3.62 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm A: Ibrutinib + Rituximab than on Arm B: Placebo + Rituximab | 4.8 | 3.23 | 9.86 | 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 | Arm A: Ibrutinib + Rituximab | Participants were randomized to receive ibrutinib 560mg orally (PO) once daily (QD) until disease progression or unacceptable toxicity and rituximab 375mg/m\^2 weekly (QW) for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m\^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent. | 214 | 334 | EG000 |
| Group 2 | Arm B: Placebo + Rituximab | Participants were randomized to received placebo PO (4 capsules) daily until disease progression or unacceptable toxicity and rituximab 375mg/m\^2 weekly for the first 4 weeks of study treatment (Cycle 1: Days 1, 8, 15, and 22). Beginning with Cycle 3, Day 1, rituximab maintenance therapy was administered as a single dose of 375 mg/m\^2 IV every 8 weeks for up to 12 additional doses (approximately 2 years) or until disease progression, unacceptable toxicity, or withdrawal of consent. | 48 | 111 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All-cause mortality and adverse event tables include events reported from the time of informed consent/enrollment to the end of the study. The median time on follow-up (or mean time participants were followed) was 58.2 months for Arm A (Ibrutinib + Rituximab) and 60.0 months for Arm B (Placebo + Rituximab).
Source ClinicalTrials.gov
Trial
- Title
- Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma
- NCT number
- NCT02947347
- Phases
- PHASE3
- Conditions
- Follicular Lymphoma
- Interventions
- Ibrutinib Oral Capsule, Placebo, Rituximab
- Lead sponsor
- Pharmacyclics LLC.
- Results first posted
- 2026-03-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02947347?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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