Comparison · NCT00112736-sae
Phase I (Erlotinib & Temsirolimus) vs Phase II (Erlotinib & Erlotinib): 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 I (Erlotinib & Temsirolimus) vs Phase II (Erlotinib & Erlotinib): serious adverse events. Trial comparisons, record NCT00112736-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00112736-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 | 0.143 | 0.0498 | 0.346 | wilson | |
| Risk in group 2 | 0.0339 | 0.00935 | 0.115 | wilson | |
| Risk difference, group 1 minus group 2 | 0.109 | -0.0148 | 0.314 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 4.21 | 0.756 | 23.5 | log | |
| Odds ratio, group 1 over group 2 | 4.75 | 0.735 | 30.7 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Phase I (Erlotinib & Temsirolimus) than on Phase II (Erlotinib & Erlotinib) | 9.18 | 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 (Erlotinib & Temsirolimus) | PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (dose escalation). Every 28 days until disease progression or unacceptable toxicity.~erlotinib: Given orally~temsirolimus: Given IV~pharmacological study: Correlative studies | 3 | 21 | EG000 |
| Group 2 | Phase II (Erlotinib & Erlotinib) | Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.~PHASE II (preoperative component): Patients who are surgical candidates may opt to undergo surgical resection of the tumor. Beginning 5-7 days before surgery, these patients receive oral erlotinib once daily until surgery. Patients also receive temsirolimus IV over 30 minutes at the MTD and then undergo surgical resection of the tumor 3-24 hours later. Beginning 2-4 weeks after surgery, patients receive temsirolimus at the MTD and erlotinib as in phase I.~therapeutic conventional surgery: Undergo surgical resection~laboratory biomarker analysis: Correlative studies | 2 | 59 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse Events were collected weekly for the first cycle and then at the start of each cycle while on treatment and at time of off study.
Source ClinicalTrials.gov
Trial
- Title
- Erlotinib and Temsirolimus in Treating Patients With Recurrent Malignant Glioma
- NCT number
- NCT00112736
- Phases
- PHASE1, PHASE2
- Conditions
Adult Anaplastic Astrocytoma, Adult Anaplastic Oligodendroglioma, Adult Diffuse Astrocytoma, Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Adult Mixed Glioma, Adult Pilocytic Astrocytoma, Adult Pineal Gland Astrocytoma, Adult Subependymal Giant Cell Astrocytoma, Recurrent Adult Brain Tumor
- Interventions
- erlotinib, temsirolimus, therapeutic conventional surgery, laboratory biomarker analysis, pharmacological study
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2015-06-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00112736?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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