Comparison · NCT01399372-sae
Chemotherapy vs Chemotherapy + Low-Dose WBRT: 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. Chemotherapy vs Chemotherapy + Low-Dose WBRT: serious adverse events. Trial comparisons, record NCT01399372-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01399372-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 | 0.512 | 0.368 | 0.654 | wilson | |
| Risk in group 2 | 0.488 | 0.346 | 0.632 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0233 | -0.181 | 0.224 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.05 | 0.686 | 1.6 | log | |
| Odds ratio, group 1 over group 2 | 1.1 | 0.471 | 2.56 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Chemotherapy than on Chemotherapy + Low-Dose WBRT | 43 | 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 | Chemotherapy | Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 3-5 weeks later by two 28-day cycles of cytarabine. | 22 | 43 | EG000 |
| Group 2 | Chemotherapy + Low-Dose WBRT | Rituximab, methotrexate, procarbazine for four 28-day cycles with vincristine for the first two cycles, followed 2-5 weeks later by 3 weeks of low-dose whole-brain radiotherapy (WBRT), followed 3-5 weeks later by two 28-day cycles of cytarabine. | 21 | 43 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- At the end of each chemotherapy 28-day cycle, then every 2 months for two years starting 4 weeks after treatment, then every 6 months for 3 years. Maximum follow-up at time of analysis was 7.3 years.
Source ClinicalTrials.gov
Trial
- Title
- Rituximab, Methotrexate, Vincristine Sulfate, Procarbazine Hydrochloride, and Cytarabine With or Without Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
- NCT number
- NCT01399372
- Phases
- PHASE2
- Conditions
- Chemotherapeutic Agent Toxicity, Cognitive/Functional Effects, Lymphoma, Neurotoxicity, Radiation Toxicity
- Interventions
- Rituximab, Cytarabine, Methotrexate, Procarbazine, Vincristine, low-dose whole-brain radiation therapy
- Lead sponsor
- Radiation Therapy Oncology Group
- Results first posted
- 2021-05-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01399372?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
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