Comparison · NCT02234050-sae
Trabectedin vs Local Standard of Care: 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. Trabectedin vs Local Standard of Care: serious adverse events. Trial comparisons, record NCT02234050-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02234050-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 | 0.426 | 0.31 | 0.551 | wilson | |
| Risk in group 2 | 0.148 | 0.0592 | 0.325 | wilson | |
| Risk difference, group 1 minus group 2 | 0.278 | 0.0667 | 0.431 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.88 | 1.11 | 7.44 | log | |
| Odds ratio, group 1 over group 2 | 4.27 | 1.32 | 13.9 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Trabectedin than on Local Standard of Care | 3.6 | 2.32 | 15 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard of care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Trabectedin | Patient will be treated with trabectedin~Trabectedin: Trabectedin will be given as a 24-hour infusion every 3 weeks at a starting dose of 1.5 mg/m2 body surface area (BSA), until one of the treatment withdrawal criteria has been met. | 26 | 61 | EG000 |
| Group 2 | Local Standard of Care | Treatment in the control arm is left to the discretion of the investigator, according to the local standard of care.~Local standard of care: Left to the discretion of the investigator | 4 | 27 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse Events (AEs) were collected from first dose of treatment (Trabectedin or SOC) up to 27 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 36 months after patient enrolment in the study.
Source ClinicalTrials.gov
Trial
- Title
- Trabectedin for Recurrent Grade II/III Meningioma
- NCT number
- NCT02234050
- Phases
- PHASE2
- Conditions
- Recurrent High Grade Meningioma
- Interventions
- Trabectedin, Local standard of care
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
- Results first posted
- 2025-07-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02234050?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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