Comparison · NCT01343277-sae
Trabectedin vs Dacarbazine: 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 Dacarbazine: serious adverse events. Trial comparisons, record NCT01343277-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01343277-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 | 0.41 | 0.362 | 0.46 | wilson | |
| Risk in group 2 | 0.302 | 0.239 | 0.375 | wilson | |
| Risk difference, group 1 minus group 2 | 0.108 | 0.0207 | 0.189 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.36 | 1.05 | 1.75 | log | |
| Odds ratio, group 1 over group 2 | 1.6 | 1.09 | 2.36 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Trabectedin than on Dacarbazine | 9.28 | 5.29 | 48.4 | 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 | Trabectedin at a dose of 1.5 milligram per meter square (mg/m\^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion. | 155 | 378 | EG000 |
| Group 2 | Dacarbazine | Dacarbazine at a dose of 1 gram per meter square (mg/m\^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion. | 52 | 172 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015]
Source ClinicalTrials.gov
Trial
- Title
- A Study of Trabectedin or Dacarbazine for the Treatment of Patients With Advanced Liposarcoma or Leiomyosarcoma
- NCT number
- NCT01343277
- Phases
- PHASE3
- Conditions
- Advanced Liposarcoma or Leiomyosarcoma
- Interventions
- Trabectedin, Dacarbazine
- Lead sponsor
- Janssen Research & Development, LLC
- Results first posted
- 2016-01-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01343277?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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