Comparison · NCT03904043-sae
Radiation + FOLFOX vs Radiation + CAPOX: 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. Radiation + FOLFOX vs Radiation + CAPOX: serious adverse events. Trial comparisons, record NCT03904043-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03904043-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 | 0.389 | 0.27 | 0.522 | wilson | |
| Risk in group 2 | 0.25 | 0.0715 | 0.591 | wilson | |
| Risk difference, group 1 minus group 2 | 0.139 | -0.222 | 0.362 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.56 | 0.447 | 5.41 | log | |
| Odds ratio, group 1 over group 2 | 1.91 | 0.352 | 10.4 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Radiation + FOLFOX than on Radiation + CAPOX | 7.2 | 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 | Radiation + FOLFOX | * Pelvic radiotherapy 5GY x 5 fractions once daily~* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily~* FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks).~ * Oxaliplatin day 1 every 14 days~ * Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available.~ * 5-FU bolus day 1 every 14 days~ * 5-FU infusion day 1 every 14 days over 46 hours~* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted | 21 | 54 | EG000 |
| Group 2 | Radiation + CAPOX | * Pelvic radiotherapy 5GY x 5 fractions once daily~* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily~* CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks).~ * Capecitabine 1000 mg/m\^2 by mouth twice per day on days 1-14 of every 21 day cycle~ * Oxaliplatin 130 mg/m\^2 intravenous on day 1 of each 21 day cycle~* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted | 2 | 8 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Source ClinicalTrials.gov
Trial
- Title
- Non-Operative Management and Early Response Assessment in Rectal Cancer
- NCT number
- NCT03904043
- Phases
- NA
- Conditions
- Adenocarcinoma of the Lower Rectum
- Interventions
- Radiation therapy, FOLFOX regimen, CAPOX regimen
- Lead sponsor
- Washington University School of Medicine
- Results first posted
- 2025-06-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03904043?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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