Comparison · NCT01183780-sae
FOLFIRI + Ramucirumab 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
Cite this record
ConductScience Library. FOLFIRI + Ramucirumab vs FOLFIRI + Placebo: serious adverse events. Trial comparisons, record NCT01183780-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01183780-sae
On this page
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 | 0.374 | 0.334 | 0.416 | wilson | |
| Risk in group 2 | 0.331 | 0.293 | 0.373 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0429 | -0.0147 | 0.1 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.13 | 0.959 | 1.33 | log | |
| Odds ratio, group 1 over group 2 | 1.21 | 0.937 | 1.55 | log | |
| Number needed to harm, for one more participant with a serious adverse event on FOLFIRI + Ramucirumab than on FOLFIRI + Placebo | 23.3 | 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 | FOLFIRI + Ramucirumab | On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m\^2 administered intravenously.~Folinic Acid: 400 mg/m\^2 administered intravenously.~5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion. | 198 | 529 | EG000 |
| Group 2 | FOLFIRI + Placebo | On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m\^2 administered intravenously.~Folinic Acid: 400 mg/m\^2 administered intravenously.~5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion. | 175 | 528 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- A Study in Second Line Metastatic Colorectal Cancer
- NCT number
- NCT01183780
- Phases
- PHASE3
- Conditions
- Colorectal Cancer
- Interventions
- Ramucirumab, Placebo, Irinotecan, Folinic Acid, 5-Fluorouracil
- Lead sponsor
- Eli Lilly and Company
- Results first posted
- 2015-07-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01183780?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01183780-sae