Comparison · NCT00060944-sae
Trabectedin 1.5 mg/m2 vs Trabectedin 0.58 mg/m2: 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 1.5 mg/m2 vs Trabectedin 0.58 mg/m2: serious adverse events. Trial comparisons, record NCT00060944-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00060944-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 | 0.369 | 0.291 | 0.455 | wilson | |
| Risk in group 2 | 0.315 | 0.242 | 0.4 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0538 | -0.061 | 0.167 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.17 | 0.834 | 1.64 | log | |
| Odds ratio, group 1 over group 2 | 1.27 | 0.76 | 2.12 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Trabectedin 1.5 mg/m2 than on Trabectedin 0.58 mg/m2 | 18.6 | 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 | Trabectedin 1.5 mg/m2 | Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion. | 48 | 130 | EG000 |
| Group 2 | Trabectedin 0.58 mg/m2 | Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion | 41 | 130 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 5 years
Source ClinicalTrials.gov
Trial
- Title
- A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer
- NCT number
- NCT00060944
- Phases
- PHASE2
- Conditions
- Liposarcoma, Leiomyosarcoma
- Interventions
- Yondelis, Yondelis, Dexamethasone, Dexamethasone
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Results first posted
- 2014-09-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00060944?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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