Comparison · NCT00561470-sae
Aflibercept/FOLFIRI vs Placebo/FOLFIRI: 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. Aflibercept/FOLFIRI vs Placebo/FOLFIRI: serious adverse events. Trial comparisons, record NCT00561470-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00561470-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 | 0.481 | 0.442 | 0.521 | wilson | |
| Risk in group 2 | 0.327 | 0.291 | 0.366 | wilson | |
| Risk difference, group 1 minus group 2 | 0.154 | 0.0989 | 0.208 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.47 | 1.28 | 1.69 | log | |
| Odds ratio, group 1 over group 2 | 1.91 | 1.51 | 2.41 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Aflibercept/FOLFIRI than on Placebo/FOLFIRI | 6.5 | 4.82 | 10.1 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Aflibercept/FOLFIRI | Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks | 294 | 611 | EG001 |
| Group 2 | Placebo/FOLFIRI | Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks | 198 | 605 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From treatment initiation to 7 February, 2011
Source ClinicalTrials.gov
Trial
- Title
- Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen
- NCT number
- NCT00561470
- Phases
- PHASE3
- Conditions
- Colorectal Neoplasms, Neoplasm Metastasis
- Interventions
- Placebo, Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®), FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin), FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
- Lead sponsor
- Sanofi
- Results first posted
- 2012-09-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00561470?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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