Comparison · NCT01498289-sae
Arm I FOLFOX vs Arm II IT: 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 I FOLFOX vs Arm II IT: serious adverse events. Trial comparisons, record NCT01498289-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01498289-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 | 0.0769 | 0.0378 | 0.15 | wilson | |
| Risk in group 2 | 0.173 | 0.111 | 0.26 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0965 | -0.192 | -0.000277 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.443 | 0.193 | 1.02 | log | |
| Odds ratio, group 1 over group 2 | 0.397 | 0.156 | 1.01 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm I FOLFOX than on Arm II IT | 10.4 | 5.21 | 3,600 | 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 | Arm I FOLFOX | FOLFOX regimen: participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, and leucovorin calcium. | 7 | 91 | EG000 |
| Group 2 | Arm II IT | IT regimen: participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m\^2, IV over 30 minutes on Day 1,8 of each 21 day cycle. | 17 | 98 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Duration of treatment and follow up until death or 3 years post registration
Source ClinicalTrials.gov
Trial
- Title
- S1201: Combination Chemo for Patients W/Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Cancer
- NCT number
- NCT01498289
- Phases
- PHASE2
- Conditions
- Adenocarcinoma of the Gastroesophageal Junction, Esophageal Cancer, Gastric Cancer
- Interventions
- FOLFOX regimen, docetaxel, fluorouracil, irinotecan hydrochloride, leucovorin calcium, oxaliplatin
- Lead sponsor
- SWOG Cancer Research Network
- Results first posted
- 2019-08-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01498289?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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