Comparison · NCT00052910-sae
Arm I (5-FU/LV) vs Arm II (ECF): 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 (5-FU/LV) vs Arm II (ECF): serious adverse events. Trial comparisons, record NCT00052910-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00052910-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 | 0.228 | 0.182 | 0.281 | wilson | |
| Risk in group 2 | 0.167 | 0.126 | 0.218 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0606 | -0.00806 | 0.128 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.36 | 0.958 | 1.94 | log | |
| Odds ratio, group 1 over group 2 | 1.47 | 0.95 | 2.27 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm I (5-FU/LV) than on Arm II (ECF) | 16.5 | 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 (5-FU/LV) | Patients receive leucovorin calcium (LV) IV (20 mg/m\^2 per day) and fluorouracil (5-FU) IV (425 mg/m\^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3. | 62 | 272 | EG000 |
| Group 2 | Arm II (ECF) | Patients receive epirubicin IV (50 mg/m\^2) over 3-15 minutes and cisplatin IV (60 mg/m\^2) over 1 hour on day 1 and 5-FU IV (200 mg/m\^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses. | 42 | 251 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Chemotherapy and Radiation Therapy After Surgery in Treating Patients With Stomach or Esophageal Cancer
- NCT number
- NCT00052910
- Phases
- PHASE3
- Conditions
- Esophageal Cancer, Gastric Cancer
- Interventions
- cisplatin, epirubicin hydrochloride, fluorouracil, leucovorin calcium, radiation therapy
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Results first posted
- 2018-07-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00052910?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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