Comparison · NCT00938470-sae
Arm I (DOC, 5FU/O/RT, Surgery) vs Arm II (5FU/O/RT, Surgery): 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. Arm I (DOC, 5FU/O/RT, Surgery) vs Arm II (5FU/O/RT, Surgery): serious adverse events. Trial comparisons, record NCT00938470-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00938470-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 | 0.206 | 0.103 | 0.368 | wilson | |
| Risk in group 2 | 0.25 | 0.127 | 0.434 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0441 | -0.254 | 0.16 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.824 | 0.328 | 2.07 | log | |
| Odds ratio, group 1 over group 2 | 0.778 | 0.236 | 2.56 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm I (DOC, 5FU/O/RT, Surgery) than on Arm II (5FU/O/RT, Surgery) | 22.7 | 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 | Arm I (DOC, 5FU/O/RT, Surgery) | Patients receive 60mg/m\^2 docetaxel (D) IV over 1 hour and 85mg/m\^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m\^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m\^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m\^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery. | 7 | 34 | EG000 |
| Group 2 | Arm II (5FU/O/RT, Surgery) | Patients receive 180 mg/m\^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m\^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery. | 7 | 28 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 2 years
Source ClinicalTrials.gov
Trial
- Title
- Docetaxel, Oxaliplatin, Capecitabine, Fluorouracil, and Radiation Therapy in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
- NCT number
- NCT00938470
- Phases
- PHASE2
- Conditions
- Adenocarcinoma of the Gastroesophageal Junction, Esophageal Cancer, Gastric Cancer
- Interventions
- capecitabine, docetaxel, fluorouracil, oxaliplatin, radiation therapy, therapeutic conventional surgery
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Results first posted
- 2017-04-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00938470?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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