Comparison · NCT00678535-sae
Cetuximab Plus Capecitabine Plus Cisplatin vs Capecitabine Plus Cisplatin: 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. Cetuximab Plus Capecitabine Plus Cisplatin vs Capecitabine Plus Cisplatin: serious adverse events. Trial comparisons, record NCT00678535-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00678535-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 | 0.536 | 0.489 | 0.582 | wilson | |
| Risk in group 2 | 0.445 | 0.399 | 0.492 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0909 | 0.0249 | 0.156 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.2 | 1.05 | 1.38 | log | |
| Odds ratio, group 1 over group 2 | 1.44 | 1.1 | 1.88 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Cetuximab Plus Capecitabine Plus Cisplatin than on Capecitabine Plus Cisplatin | 11 | 6.42 | 40.1 | 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 | Cetuximab Plus Capecitabine Plus Cisplatin | Cetuximab weekly (initial dose 400 milligram per square meter \[mg/m\^2\] followed by 250 mg/m\^2 intravenous infusion), cisplatin (3-week cycle, 80 mg/m\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\^2 orally twice daily for 14 days ) until documented disease progression, unacceptable toxicity, or withdrawal of consent. | 239 | 446 | EG000 |
| Group 2 | Capecitabine Plus Cisplatin | Cisplatin (3-week cycle, 80 mg/m\^2 intravenous infusion on Day 1) and capecitabine (3-week cycle, 1000 mg/m\^2 orally twice daily for 14 days) until documented disease progression, unacceptable toxicity, or withdrawal of consent. | 194 | 436 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Time from first dose up to 30 days after the last dose of study treatment.
Source ClinicalTrials.gov
Trial
- Title
- Erbitux in Combination With Xeloda and Cisplatin in Advanced Esophago-gastric Cancer
- NCT number
- NCT00678535
- Phases
- PHASE3
- Conditions
- Gastric Cancer
- Interventions
- Cetuximab, Capecitabine, Cisplatin
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Results first posted
- 2013-05-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00678535?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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