Comparison · NCT00113607-sae
Trabectedin/DOXIL vs DOXIL: 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/DOXIL vs DOXIL: serious adverse events. Trial comparisons, record NCT00113607-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00113607-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 | 0.399 | 0.348 | 0.453 | wilson | |
| Risk in group 2 | 0.309 | 0.262 | 0.361 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0903 | 0.0175 | 0.162 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.29 | 1.05 | 1.59 | log | |
| Odds ratio, group 1 over group 2 | 1.49 | 1.08 | 2.05 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Trabectedin/DOXIL than on DOXIL | 11.1 | 6.18 | 57.2 | 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 | Trabectedin/DOXIL | 30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks | 133 | 333 | EG000 |
| Group 2 | DOXIL | 50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks | 102 | 330 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the time of the first study-related procedure until up to 30 days after administration of the last dose of study medication.
Source ClinicalTrials.gov
Trial
- Title
- An Efficacy and Safety Study for Yondelis (Trabectedin) in Patients With Advanced Relapsed Ovarian Cancer
- NCT number
- NCT00113607
- Phases
- PHASE3
- Conditions
- Ovarian Cancer
- Interventions
- Trabectedin, DOXIL, Dexamethasone
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Results first posted
- 2013-08-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00113607?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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