Comparison · NCT01511562-sae
Arm I vs Arm II: 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 I vs Arm II: serious adverse events. Trial comparisons, record NCT01511562-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01511562-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 | 0.389 | 0.27 | 0.522 | wilson | |
| Risk in group 2 | 0.611 | 0.478 | 0.73 | wilson | |
| Risk difference, group 1 minus group 2 | -0.222 | -0.39 | -0.0338 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.636 | 0.428 | 0.946 | log | |
| Odds ratio, group 1 over group 2 | 0.405 | 0.187 | 0.878 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm I than on Arm II | 4.5 | 2.57 | 29.6 | 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 I | Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo stem cell transplant. \> \> carmustine: Given IV \>~* thiotepa: Given IV \>~* stem cell transplant \>~* G-CSF | 21 | 54 | EG000 |
| Group 2 | Arm II | Patients undergo induction therapy for five cycles as defined in the protocol. Patients undergo consolidation chemotherapy. \>~* cytarabine: Given IV \>~* etoposide: Given IV \>~* G-CSF | 33 | 54 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 7 years
Source ClinicalTrials.gov
Trial
- Title
- Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma
- NCT number
- NCT01511562
- Phases
- PHASE2
- Conditions
- Lymphoma
- Interventions
- carmustine, cytarabine, etoposide, thiotepa, stem cell transplant, G-CSF
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Results first posted
- 2026-01-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01511562?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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