Comparison · NCT01402063-sae
Radiation Plus PPX and Maintenance vs Radiation + Temozolomide and Maintenance: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Radiation Plus PPX and Maintenance vs Radiation + Temozolomide and Maintenance: serious adverse events. Trial comparisons, record NCT01402063-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01402063-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 | 0.317 | 0.196 | 0.47 | wilson | |
| Risk in group 2 | 0.389 | 0.203 | 0.614 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0718 | -0.327 | 0.169 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.815 | 0.392 | 1.7 | log | |
| Odds ratio, group 1 over group 2 | 0.73 | 0.23 | 2.31 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Radiation Plus PPX and Maintenance than on Radiation + Temozolomide and Maintenance | 13.9 | 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 | Radiation Plus PPX and Maintenance | Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~\+ intravenous PPX every week x 6 weeks for a total of 6 treatments~PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum. | 13 | 41 | EG000 |
| Group 2 | Radiation + Temozolomide and Maintenance | Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~\+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days~Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum | 7 | 18 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug
Source ClinicalTrials.gov
Trial
- Title
- PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation
- NCT number
- NCT01402063
- Phases
- PHASE2
- Conditions
- Glioblastoma Multiforme
- Interventions
- PPX (CT2103), Temozolomide
- Lead sponsor
- Brown University
- Results first posted
- 2015-06-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01402063?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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