Comparison · NCT00154102-sae
Cetuximab Plus FOLFIRI vs FOLFIRI Alone: 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. Cetuximab Plus FOLFIRI vs FOLFIRI Alone: serious adverse events. Trial comparisons, record NCT00154102-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00154102-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 | 0.438 | 0.399 | 0.478 | wilson | |
| Risk in group 2 | 0.339 | 0.302 | 0.378 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0995 | 0.0444 | 0.154 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.29 | 1.12 | 1.49 | log | |
| Odds ratio, group 1 over group 2 | 1.52 | 1.21 | 1.92 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Cetuximab Plus FOLFIRI than on FOLFIRI Alone | 10.1 | 6.51 | 22.5 | 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 | Cetuximab Plus FOLFIRI | Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops.~Safety population: includes all treated subjects. | 263 | 600 | EG000 |
| Group 2 | FOLFIRI Alone | Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops.~Safety population: includes all treated subjects | 204 | 602 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Time from first dose up to 30 days after the last dose of study treatment.
Source ClinicalTrials.gov
Trial
- Title
- Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL)
- NCT number
- NCT00154102
- Phases
- PHASE3
- Conditions
- Epidermal Growth Factor Receptor (EGFR) Expressing Metastatic Colorectal Cancer
- Interventions
- Cetuximab, FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Results first posted
- 2011-02-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00154102?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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