Comparison · NCT03829462-sae
Irinotecan + Regorafenib (REGIRI) vs Regorafenib: 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. Irinotecan + Regorafenib (REGIRI) vs Regorafenib: serious adverse events. Trial comparisons, record NCT03829462-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03829462-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 | 0.636 | 0.466 | 0.778 | wilson | |
| Risk in group 2 | 0.606 | 0.437 | 0.753 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0303 | -0.195 | 0.251 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.05 | 0.72 | 1.53 | log | |
| Odds ratio, group 1 over group 2 | 1.14 | 0.42 | 3.08 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Irinotecan + Regorafenib (REGIRI) than on Regorafenib | 33 | 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 | Irinotecan + Regorafenib (REGIRI) | irinotecan (180 mg/m2) at day1 of each cycle + regorafenib (160 mg/day) from day 2 to day 8~Regorafenib: regorafenib tab 40 mg i.e 160 mg/day~Irinotecan: irinotecan 120 mg/m2 cycle 1, 150 mg/m2 cycle 2, 180 mg/m2 cycle 3 and more | 21 | 33 | EG000 |
| Group 2 | Regorafenib | Regorafenib (160 mg/day) for 3 weeks followed by 1 week off~Regorafenib: regorafenib tab 40 mg i.e 160 mg/day | 20 | 33 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse Events were collected from the baseline up to one month after the last cycle of chemotherapy, up to 36 months. All-Cause Mortality was assessed through study completion, up to 36 months.
Source ClinicalTrials.gov
Trial
- Title
- Assessing a Regorafenib-irinotecan Combination Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients
- NCT number
- NCT03829462
- Phases
- PHASE3
- Conditions
- Metastatic Colorectal Cancer (mCRC)
- Interventions
- Regorafenib, Irinotecan
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Results first posted
- 2025-07-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03829462?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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