Comparison · NCT00009737-sae
Capecitabine vs 5-Fluorouracil + Leucovorin: 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. Capecitabine vs 5-Fluorouracil + Leucovorin: serious adverse events. Trial comparisons, record NCT00009737-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00009737-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 | 0.182 | 0.159 | 0.207 | wilson | |
| Risk in group 2 | 0.187 | 0.164 | 0.213 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00495 | -0.0393 | 0.0293 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.974 | 0.808 | 1.17 | log | |
| Odds ratio, group 1 over group 2 | 0.968 | 0.77 | 1.22 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Capecitabine than on 5-Fluorouracil + Leucovorin | 202 | 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 | Capecitabine | Participants received capecitabine 1250 (mg/m \^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks). | 181 | 995 | EG000 |
| Group 2 | 5-Fluorouracil + Leucovorin | Participants received leucovorin 20 mg/m \^ 2 followed by 5-fluorouracil at 425 mg/m \^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks). | 182 | 974 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to Week 29
Source ClinicalTrials.gov
Trial
- Title
- A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer
- NCT number
- NCT00009737
- Phases
- PHASE3
- Conditions
- Colorectal Cancer
- Interventions
- 5-Fluorouracil, Leucovorin, Capecitabine [Xeloda]
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2016-06-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00009737?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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