Comparison · NCT04117945-f1be76f1
Arm A (Regorafenib) vs Arm B (Cetuximab, Panitumumab, Irinotecan): Number of Patients Experiencing 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. Arm A (Regorafenib) vs Arm B (Cetuximab, Panitumumab, Irinotecan): Number of Patients Experiencing Adverse Events. Trial comparisons, record NCT04117945-f1be76f1. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04117945-f1be76f1
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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 | 1 | 0.51 | 1 | wilson | |
| Risk in group 2 | 0.667 | 0.208 | 0.939 | wilson | |
| Risk difference, group 1 minus group 2 | 0.333 | -0.227 | 0.792 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.5 | 0.674 | 3.34 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on Arm A (Regorafenib) than on Arm B (Cetuximab, Panitumumab, Irinotecan) | 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 | Arm A (Regorafenib) | Patients receive regorafenib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. If received as initial treatment, patients who experience disease progression may switch over to the other treatment regimen, per treating physician discretion.\>~\> Regorafenib: Given PO | 4 | 4 | OG000 |
| Group 2 | Arm B (Cetuximab, Panitumumab, Irinotecan) | Patients receive cetuximab or panitumumab IV over 30-90 minutes on days 1 and 15. Patients may also receive irinotecan IV on days 1 and 15 as determined by the study doctor. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. If received as initial treatment, patients who experience disease progression may switch over to the other treatment regimen, per treating physician discretion.\>~\> Cetuximab: Given IV\>~\> Irinotecan: Given IV\>~\> Panitumumab: Given IV | 2 | 3 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Patients Experiencing Adverse Events
- Description
The number of patients who experience a grade 3 or higher adverse event (Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v.\] 5.0), regardless of attribution, will be reported by arm.
- Time frame
- 20 months
- Population
- Only eligible patients were included in analysis
Source ClinicalTrials.gov
Trial
- Title
- Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer
- NCT number
- NCT04117945
- Phases
- PHASE2
- Conditions
BRAF V600E Negative, KRAS Gene Mutation Negative, Locally Advanced Unresectable Colorectal Adenocarcinoma, Metastatic Colorectal Adenocarcinoma, NRAS Gene Mutation Negative, Stage III Colorectal Cancer AJCC v8, Stage IIIA Colorectal Cancer AJCC v8, Stage IIIB Colorectal Cancer AJCC v8, Stage IIIC Colorectal Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8, Stage IVA Colorectal Cancer AJCC v8, Stage IVB Colorectal Cancer AJCC v8, Stage IVC Colorectal Cancer AJCC v8
- Interventions
- Cetuximab, Irinotecan, Panitumumab, Regorafenib
- Lead sponsor
- Academic and Community Cancer Research United
- Results first posted
- 2024-09-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04117945?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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