Comparison · NCT01846611-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 NCT01846611-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01846611-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 | 0.413 | 0.357 | 0.47 | wilson | |
| Risk in group 2 | 0.206 | 0.163 | 0.257 | wilson | |
| Risk difference, group 1 minus group 2 | 0.207 | 0.132 | 0.279 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.01 | 1.53 | 2.62 | log | |
| Odds ratio, group 1 over group 2 | 2.71 | 1.87 | 3.94 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Trabectedin + DOXIL than on DOXIL | 4.83 | 3.58 | 7.6 | 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 | Trabectedin + DOXIL | Participants received DOXIL 30 milligram per meter square (mg/m\^2) administered as an intravenous (IV) infusion over approximately 90 minutes followed by trabectedin 1.1 mg/m\^2 administered as an IV infusion over approximately 3 hours, on Day 1 of each treatment cycle (21 days cycle) every 3 weeks. Participants were pretreated with 20 mg dexamethasone IV (or an equivalent IV corticosteroid) approximately 30 minutes prior to initiation of infusion of DOXIL IV. | 118 | 286 | EG000 |
| Group 2 | DOXIL | Participants received DOXIL 50 mg/m\^2 administered as an IV infusion over approximately 90 minutes on Day 1 of each treatment cycle (28 days cycle), every 4 weeks. | 58 | 282 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 4.3 years
Source ClinicalTrials.gov
Trial
- Title
- A Study Comparing the Combination of Trabectedin (YONDELIS) and DOXIL/CAELYX With DOXIL/CAELYX for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
- NCT number
- NCT01846611
- Phases
- PHASE3
- Conditions
- Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms
- Interventions
- Trabectedin, DOXIL, Dexamethasone, DOXIL
- Lead sponsor
- Janssen Research & Development, LLC
- Results first posted
- 2019-02-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01846611?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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