Comparison · NCT00068250-366ddfca
Phase I: Temozolomide 100mg vs Phase I: Temozolomide150 mg: Number of Phase I Participants Experiencing Toxicity
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. Phase I: Temozolomide 100mg vs Phase I: Temozolomide150 mg: Number of Phase I Participants Experiencing Toxicity. Trial comparisons, record NCT00068250-366ddfca. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00068250-366ddfca
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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 | 0.167 | 0.0301 | 0.564 | wilson | |
| Risk in group 2 | 0.5 | 0.188 | 0.812 | wilson | |
| Risk difference, group 1 minus group 2 | -0.333 | -0.674 | 0.172 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.333 | 0.047 | 2.37 | log | |
| Odds ratio, group 1 over group 2 | 0.2 | 0.0137 | 2.91 | log | |
| Number needed to treat, for one fewer participant with the outcome on Phase I: Temozolomide 100mg than on Phase I: Temozolomide150 mg | 3 | 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 | Phase I: Temozolomide 100mg | Phase I: Temozolomide 100mg | 1 | 6 | OG000 |
| Group 2 | Phase I: Temozolomide150 mg | Phase I: Temozolomide 150 mg | 3 | 6 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Phase I Participants Experiencing Toxicity
- Description
A dose limiting toxicity (DLT) is defined as any grade 3 or 4 non-hematological toxicity (other than grade 3 nausea/vomiting) or any hematological toxicity resulting in the discontinuation of temozolomide. Toxicity evaluation for this dose escalation includes all toxicities occurring prior to the start of radiation therapy. If the patient did not receive radiation therapy, then toxicity evaluation included all toxicities occurring through week 15. Any grade 5 toxicity would result in immediate suspension of accrual.
- Time frame
- From start of treatment to 10 weeks if radiation therapy received, to 15 weeks if not.
- Population
- Eligible patients on Phase I arms who started study treatment
Source ClinicalTrials.gov
Trial
- Title
- Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
- NCT number
- NCT00068250
- Phases
- PHASE1, PHASE2
- Conditions
- Brain and Central Nervous System Tumors, Lymphoma
- Interventions
- rituximab, methotrexate, temozolomide 100 mg/m^2, temozolomide 150 mg/m^2, temozolomide 200 mg/m^2, radiation therapy, post-radiation therapy temozolomide
- Lead sponsor
- Radiation Therapy Oncology Group
- Results first posted
- 2018-02-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00068250?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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