Comparison · NCT00337103-sae
Eribulin Mesylate 1.4 mg/m^2 vs Capecitabine 2.5 g/m^2/Day: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Eribulin Mesylate 1.4 mg/m^2 vs Capecitabine 2.5 g/m^2/Day: serious adverse events. Trial comparisons, record NCT00337103-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00337103-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 | 0.175 | 0.145 | 0.209 | wilson | |
| Risk in group 2 | 0.211 | 0.179 | 0.247 | wilson | |
| Risk difference, group 1 minus group 2 | -0.036 | -0.0827 | 0.0109 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.829 | 0.649 | 1.06 | log | |
| Odds ratio, group 1 over group 2 | 0.793 | 0.586 | 1.07 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Eribulin Mesylate 1.4 mg/m^2 than on Capecitabine 2.5 g/m^2/Day | 27.8 | 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 | Eribulin Mesylate 1.4 mg/m^2 | Eribulin mesylate 1.4 mg/m\^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days | 95 | 544 | EG000 |
| Group 2 | Capecitabine 2.5 g/m^2/Day | Capecitabine : Capecitabine 2.5 g/m\^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days | 115 | 546 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- First dose of study drug (Baseline) up to 30 days after last dose of study drug (up to approximately 6 years 3 months)
Source ClinicalTrials.gov
Trial
- Title
- E7389 Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes
- NCT number
- NCT00337103
- Phases
- PHASE3
- Conditions
- Metastatic Breast Cancer
- Interventions
- Eribulin Mesylate, Capecitabine
- Lead sponsor
- Eisai Inc.
- Results first posted
- 2013-09-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00337103?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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