Comparison · NCT00457691-sae
FOLFIRI + Sunitinib vs FOLFIRI + Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. FOLFIRI + Sunitinib vs FOLFIRI + Placebo: serious adverse events. Trial comparisons, record NCT00457691-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00457691-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 | 0.443 | 0.394 | 0.493 | wilson | |
| Risk in group 2 | 0.293 | 0.249 | 0.341 | wilson | |
| Risk difference, group 1 minus group 2 | 0.15 | 0.0815 | 0.216 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.51 | 1.25 | 1.83 | log | |
| Odds ratio, group 1 over group 2 | 1.92 | 1.42 | 2.59 | log | |
| Number needed to harm, for one more participant with a serious adverse event on FOLFIRI + Sunitinib than on FOLFIRI + Placebo | 6.67 | 4.63 | 12.3 | 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 | FOLFIRI + Sunitinib | Intravenous (IV) irinotecan (180 milligrams per square meter \[mg/m²\]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle. | 170 | 384 | EG000 |
| Group 2 | FOLFIRI + Placebo | IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle. | 111 | 379 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer
- NCT number
- NCT00457691
- Phases
- PHASE3
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- 5 fluorouracil, irinotecan, levo- leucovorin, sunitinib, 5 fluorouracil, irinotecan, levo- leucovorin, placebo
- Lead sponsor
- Pfizer
- Results first posted
- 2011-06-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00457691?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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