Comparison · NCT03345095-sae
Experimental Arm vs Standard Arm: 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. Experimental Arm vs Standard Arm: serious adverse events. Trial comparisons, record NCT03345095-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03345095-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 | 0.374 | 0.321 | 0.429 | wilson | |
| Risk in group 2 | 0.269 | 0.222 | 0.323 | wilson | |
| Risk difference, group 1 minus group 2 | 0.104 | 0.0298 | 0.177 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.39 | 1.09 | 1.76 | log | |
| Odds ratio, group 1 over group 2 | 1.62 | 1.15 | 2.29 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Experimental Arm than on Standard Arm | 9.58 | 5.64 | 33.6 | from the risk difference interval |
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 | Experimental Arm | Radiotherapy + Temozolomide + Marizomib followed by adjuvant Temozolomide + Marizomib~Marizomib: Intravenous administration of Marizomib~Temozolomide: Oral Administration of Temozolomide~radiotherapy: 60 Gy in 30 fractions over 6 weeks | 114 | 305 | EG000 |
| Group 2 | Standard Arm | Radiotherapy + Temozolomide followed by adjuvant Temozolomide~Temozolomide: Oral Administration of Temozolomide~radiotherapy: 60 Gy in 30 fractions over 6 weeks | 80 | 297 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse Events (AEs) were collected from first dose of radiotherapy up to 49 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 49 months after patient enrolment in the study.
Source ClinicalTrials.gov
Trial
- Title
- A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma
- NCT number
- NCT03345095
- Phases
- PHASE3
- Conditions
- Newly Diagnosed Glioblastoma
- Interventions
- Marizomib, Temozolomide, radiotherapy
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
- Results first posted
- 2024-01-31
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03345095?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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