Comparison · NCT01381692-sae
Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone) vs Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone): 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 (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone) vs Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone): serious adverse events. Trial comparisons, record NCT01381692-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01381692-sae
On this page
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 | 1 | 0.646 | 1 | wilson | |
| Risk in group 2 | 0.5 | 0.0945 | 0.905 | wilson | |
| Risk difference, group 1 minus group 2 | 0.5 | -0.0385 | 0.905 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2 | 0.5 | 8 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
Number needed to harm, for one more participant with a serious adverse event on Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone) than on Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone) | 2 | 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 | Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone) | Patients receive temsirolimus IV at dose level 1 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. | 7 | 7 | EG000 |
| Group 2 | Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone) | Patients receive temsirolimus IV at dose level 2 over 30-60 minutes on days 1, 8, 15, and 22, rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 (of courses 1 and 4 only), bortezomib IV or SC and dexamethasone PO on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. | 1 | 2 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
Source ClinicalTrials.gov
Trial
- Title
Bortezomib, Rituximab, and Dexamethasone With or Without Temsirolimus in Treating Patients With Untreated or Relapsed Waldenstrom Macroglobulinemia or Relapsed or Refractory Mantle Cell or Follicular Lymphoma
- NCT number
- NCT01381692
- Phases
- PHASE1, PHASE2
- Conditions
Recurrent Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Small Lymphocytic Lymphoma, Recurrent Waldenstrom Macroglobulinemia, Refractory Follicular Lymphoma, Refractory Mantle Cell Lymphoma, Refractory Marginal Zone Lymphoma, Refractory Non-Hodgkin Lymphoma, Refractory Small Lymphocytic Lymphoma
- Interventions
- Bortezomib, Dexamethasone, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Rituximab, Temsirolimus
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2021-05-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01381692?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.
For software
Read this comparison from software.
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GET https://conductscience.org/api/comparisons/v1/NCT01381692-sae