Comparison · NCT00081289-sae
Neoadjuvant Chemoradiation With Irinotecan vs Neoadjuvant Chemoradiation With Oxaliplatin: 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. Neoadjuvant Chemoradiation With Irinotecan vs Neoadjuvant Chemoradiation With Oxaliplatin: serious adverse events. Trial comparisons, record NCT00081289-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00081289-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 | 0.529 | 0.413 | 0.641 | wilson | |
| Risk in group 2 | 0.529 | 0.412 | 0.643 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00084 | -0.163 | 0.161 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.998 | 0.729 | 1.37 | log | |
| Odds ratio, group 1 over group 2 | 0.997 | 0.511 | 1.94 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Neoadjuvant Chemoradiation With Irinotecan than on Neoadjuvant Chemoradiation With Oxaliplatin | 1,190 | 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 | Neoadjuvant Chemoradiation With Irinotecan | Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery. | 37 | 70 | EG000 |
| Group 2 | Neoadjuvant Chemoradiation With Oxaliplatin | Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery. | 36 | 68 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer
- NCT number
- NCT00081289
- Phases
- PHASE2
- Conditions
- Colorectal Cancer
- Interventions
- Radiation Therapy, Capecitabine 1650 mg/m^2/day, Capecitabine 1200 mg/m^2/day, Irinotecan, Oxaliplatin, Surgery, Folinic Acid, Fluorouracil, Oxaliplatin
- Lead sponsor
- Radiation Therapy Oncology Group
- Results first posted
- 2013-11-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00081289?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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