Comparison · NCT00525915-sae
Arm A: Chemo With Radiation Treatment vs Arm B: Pre-Op Chemo + Chemo With Radiation Treatment: 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 A: Chemo With Radiation Treatment vs Arm B: Pre-Op Chemo + Chemo With Radiation Treatment: serious adverse events. Trial comparisons, record NCT00525915-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00525915-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 | 0.159 | 0.0886 | 0.268 | wilson | |
| Risk in group 2 | 0.111 | 0.0549 | 0.212 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0476 | -0.0753 | 0.171 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.43 | 0.58 | 3.52 | log | |
| Odds ratio, group 1 over group 2 | 1.51 | 0.535 | 4.25 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm A: Chemo With Radiation Treatment than on Arm B: Pre-Op Chemo + Chemo With Radiation Treatment | 21 | 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 A: Chemo With Radiation Treatment | For 5 weeks, Chemotherapy (Chemo) of 5-Fluorouracil (5-FU) 250 mg/m\^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m\^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery. | 10 | 63 | EG000 |
| Group 2 | Arm B: Pre-Op Chemo + Chemo With Radiation Treatment | Pre-Operative Chemo 5-FU 2.2 mg/m\^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m\^2 IV over 2 hours on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A) | 7 | 63 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events recorded for all participants from randomization until 30 days following last dose of study treatment (including withdrawal because of toxicity). Overall active study period was from April 2005 to July 2012.
Source ClinicalTrials.gov
Trial
- Title
- Oxaliplatin-Based Chemotherapy and Chemoradiotherapy or Chemoradiotherapy in Esophageal or Gastroesophageal Carcinoma
- NCT number
- NCT00525915
- Phases
- PHASE2
- Conditions
- Esophageal Cancer, Gastroesophageal Cancer
- Interventions
- 5-Fluorouracil, Oxaliplatin, Radiation Therapy, Surgery
- Lead sponsor
- M.D. Anderson Cancer Center
- Results first posted
- 2015-02-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00525915?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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