Comparison · NCT01515748-sae
Surgery + Adjuvant Chemotherapy (SC) vs Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC): 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. Surgery + Adjuvant Chemotherapy (SC) vs Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC): serious adverse events. Trial comparisons, record NCT01515748-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01515748-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 | 0.292 | 0.233 | 0.36 | wilson | |
| Risk in group 2 | 0.423 | 0.363 | 0.486 | wilson | |
| Risk difference, group 1 minus group 2 | -0.131 | -0.218 | -0.0403 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.691 | 0.531 | 0.899 | log | |
| Odds ratio, group 1 over group 2 | 0.563 | 0.377 | 0.84 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Surgery + Adjuvant Chemotherapy (SC) than on Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | 7.64 | 4.6 | 24.8 | 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 | Surgery + Adjuvant Chemotherapy (SC) | Participants underwent surgery within 2 weeks after randomization followed by adjuvant chemotherapy with S-1 \[(Gimeracil) + Oxo (Oteracil)\] 40 mg/m\^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 10 years). | 57 | 195 | EG000 |
| Group 2 | Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) | Participants received neo-adjuvant chemotherapy with Docetaxel 50 mg/m\^2 IV for \>= 1 hr on Day 1 of each treatment cycle plus Oxaliplatin 100 mg/m\^2 IV for \>=2 hr on Day 1 of each treatment cycle plus S-1 \[(Gimeracil) + Oxo (Oteracil)\] 40 mg/m\^2 administered orally twice daily from Day 1 to 14, of each treatment cycle followed by surgery approximately 1-3 weeks after completion of neo-adjuvant chemotherapy and adjuvant chemotherapy with S-1 \[(Gimeracil) + Oxo (Oteracil)\] 40 mg/m\^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 10 years). | 102 | 241 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- AE data was collected from the time of signed informed consent to 30 days following the last administration of study treatment (maximum duration: up to 10 years)
Source ClinicalTrials.gov
Trial
- Title
- Docetaxel+Oxaliplatin+S-1 (DOS) Regimen as Neoadjuvant Chemotherapy in Advanced Gastric Cancer
- NCT number
- NCT01515748
- Phases
- PHASE3
- Conditions
- Gastric Cancer
- Interventions
- Docetaxel (XRP6976), Oxaliplatin (SR96669), S-1 (1-(2-tetrahydrofuryl)-5-fluorouracil + 5-chloro-2, 4-dihydroxypyridine (CDHP) (Gimeracil) + Oxo (Oteracil)
- Lead sponsor
- Sanofi
- Results first posted
- 2020-03-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01515748?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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