Comparison · NCT01327885-sae
Arm A: Eribulin Mesylate vs Arm B: 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. Arm A: Eribulin Mesylate vs Arm B: Dacarbazine: serious adverse events. Trial comparisons, record NCT01327885-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01327885-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 | 0.333 | 0.275 | 0.397 | wilson | |
| Risk in group 2 | 0.317 | 0.26 | 0.381 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0164 | -0.0697 | 0.102 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.05 | 0.806 | 1.37 | log | |
| Odds ratio, group 1 over group 2 | 1.08 | 0.727 | 1.6 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm A: Eribulin Mesylate than on Arm B: Dacarbazine | 61.1 | 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 | Arm A: Eribulin Mesylate | Eribulin mesylate at a dose of 1.4 mg/m\^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle. | 76 | 228 | EG000 |
| Group 2 | Arm B: Dacarbazine | Dacarbazine at a dose of 850 mg/m\^2, 1000 mg/m\^2, or 1200 mg/m\^2 (as selected by the Principal Investigator \[PI\] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle. | 71 | 224 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From date of signing of informed consent up to 30 days after the last dose of study treatment, up to 5 years 5 months
Source ClinicalTrials.gov
Trial
- Title
- Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma
- NCT number
- NCT01327885
- Phases
- PHASE3
- Conditions
- Soft Tissue Sarcoma
- Interventions
- Eribulin mesylate 1.4 mg/m^2 intravenous, Dacarbazine of 850 mg/m^2, or 1,000 mg/m^2, or 1,200 mg/m^2 IV
- Lead sponsor
- Eisai Inc.
- Results first posted
- 2017-02-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01327885?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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