Comparison · NCT02340949-sae
mFOLFOX6 + Aflibercept vs mFOLFOX6: 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. mFOLFOX6 + Aflibercept vs mFOLFOX6: serious adverse events. Trial comparisons, record NCT02340949-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02340949-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 | 0.391 | 0.307 | 0.483 | wilson | |
| Risk in group 2 | 0.246 | 0.158 | 0.363 | wilson | |
| Risk difference, group 1 minus group 2 | 0.145 | 0.00102 | 0.272 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.59 | 0.981 | 2.58 | log | |
| Odds ratio, group 1 over group 2 | 1.97 | 1 | 3.88 | log | |
| Number needed to harm, for one more participant with a serious adverse event on mFOLFOX6 + Aflibercept than on mFOLFOX6 | 6.89 | 3.67 | 979 | from the risk difference interval |
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 | mFOLFOX6 + Aflibercept | \- mFOLFOX-6 scheme: 5-Fluoruracil \[5-FU\], oxaliplatin and leucovorin will be administered intravenously once every 14 days according to mFOLFOX-6 scheme:~Day 1: Oxaliplatin 85 mg/m² IV infusion in 250-500 mL and leucovorin 200 mg/m² IV, both over two hours, followed by 5-FU 400 mg/m² IV bolus and a 46 h infusion of 5-FU 2400 mg/m².~\- Aflibercept, will be administered intravenously (I.V.) at doses of 4 mg/Kg on Day 1 every 14 days. Aflibercept will be supplied to sites by the study Sponsor as 4 ml vials at a concentration of 25 mg/ml.~Treatment will continue until six cycles are administered unless unacceptable toxicity or progression occurs.~Aflibercept: Administered I.V. at doses of 4 mg/Kg on Day 1 every 14 days. It will be supplied to sites by Sponsor as 4 ml vials at a concentration of 25 mg/ml~5-Fluoruracil: Once every 14 days. Day 1: 400 mg/m2 I.V. bolus and a 46 h infusion of 5-FU 2400 mg/m2~Oxaliplatin: Once every 14 days. Day 1: 85 mg/m2 I.V. infusion in 250-500 mL, over two hours, followed by 5-FU~Leucovorin: Once every 14 days. Day 1: 200 mg/m2 I.V., over two hours, followed by 5-FU | 45 | 115 | EG000 |
| Group 2 | mFOLFOX6 | \- mFOLFOX-6 scheme: 5-Fluoruracil \[5-FU\], oxaliplatin and leucovorin will be administered intravenously once every 14 days according to mFOLFOX-6 scheme:~Day 1: Oxaliplatin 85 mg/m² IV infusion in 250-500 mL and leucovorin 200 mg/m² IV, both over two hours, followed by 5-FU 400 mg/m² IV bolus and a 46 h infusion of 5-FU 2400 mg/m².~Treatment will continue until six cycles are administered unless unacceptable toxicity or progression occurs.~5-Fluoruracil: Once every 14 days. Day 1: 400 mg/m2 I.V. bolus and a 46 h infusion of 5-FU 2400 mg/m2~Oxaliplatin: Once every 14 days. Day 1: 85 mg/m2 I.V. infusion in 250-500 mL, over two hours, followed by 5-FU~Leucovorin: Once every 14 days. Day 1: 200 mg/m2 I.V., over two hours, followed by 5-FU | 16 | 65 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From Baseline to study completion, within an general time frame of 3 years per study protocol
Source ClinicalTrials.gov
Trial
- Title
- Induction FOLFOX With or Without Aflibercept Followed by Chemoradiation in High Risk Locally Advanced Rectal Cancer
- NCT number
- NCT02340949
- Phases
- PHASE2
- Conditions
- Rectal Cancer
- Interventions
- Aflibercept, 5-Fluoruracil, Oxaliplatin, Leucovorin
- Lead sponsor
- Grupo Espanol Multidisciplinario del Cancer Digestivo
- Results first posted
- 2021-05-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02340949?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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