Comparison · NCT00045110-sae
Phase 1 Dose Escalation vs Phase 2 Recurrent Malignant Gliomas and Nonprogressive Gbm: 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. Phase 1 Dose Escalation vs Phase 2 Recurrent Malignant Gliomas and Nonprogressive Gbm: serious adverse events. Trial comparisons, record NCT00045110-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00045110-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 | 0 | 0.107 | wilson | |
| Risk in group 2 | 0.0202 | 0.00556 | 0.0707 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0202 | -0.0707 | 0.088 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with a serious adverse event on Phase 1 Dose Escalation than on Phase 2 Recurrent Malignant Gliomas and Nonprogressive Gbm | 49.5 | 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 1 Dose Escalation | Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis. | 0 | 32 | EG000 |
| Group 2 | Phase 2 Recurrent Malignant Gliomas and Nonprogressive Gbm | Phase II: Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose.~patients requiring surgery were treated 7 days prior to tumor removal; PK analysis and effects of erlotinib on epidermal growth factor receptor (EGFR)~erlotinib hydrochloride given orally~Other: pharmacological study, laboratory biomarker analysis. | 2 | 99 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 2 years
Source ClinicalTrials.gov
Trial
- Title
- Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma
- NCT number
- NCT00045110
- Phases
- PHASE1, PHASE2
- Conditions
Adult Anaplastic Astrocytoma, Adult Anaplastic Oligodendroglioma, Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Adult Grade I Meningioma, Adult Grade II Meningioma, Adult Grade III Meningioma, Recurrent Adult Brain Tumor
- Interventions
- erlotinib hydrochloride, laboratory biomarker analysis, pharmacological study
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2017-07-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00045110?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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