Comparison · NCT01646021-sae
Ibrutinib vs Temsirolimus: 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. Ibrutinib vs Temsirolimus: serious adverse events. Trial comparisons, record NCT01646021-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01646021-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 | 0.568 | 0.485 | 0.648 | wilson | |
| Risk in group 2 | 0.597 | 0.514 | 0.675 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0288 | -0.143 | 0.0862 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.952 | 0.78 | 1.16 | log | |
| Odds ratio, group 1 over group 2 | 0.888 | 0.551 | 1.43 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Ibrutinib than on Temsirolimus | 34.8 | 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 | Ibrutinib | Participants received 560 milligram (mg) ibrutinib (4\*140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle. | 79 | 139 | EG000 |
| Group 2 | Temsirolimus | Participants received Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period. | 83 | 139 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Approximately up to 4 years
Source ClinicalTrials.gov
Trial
- Title
- Study of Ibrutinib (a Bruton's Tyrosine Kinase Inhibitor), Versus Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy
- NCT number
- NCT01646021
- Phases
- PHASE3
- Conditions
- Mantle Cell Lymphoma
- Interventions
- Ibrutinib, Temsirolimus
- Lead sponsor
- Janssen Research & Development, LLC
- Results first posted
- 2017-03-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01646021?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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