Comparison · NCT03504423-sae
CPI-613, mFolfirinox vs Folfirinox: 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. CPI-613, mFolfirinox vs Folfirinox: serious adverse events. Trial comparisons, record NCT03504423-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03504423-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 | 0.541 | 0.48 | 0.6 | wilson | |
| Risk in group 2 | 0.566 | 0.502 | 0.628 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0254 | -0.112 | 0.062 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.955 | 0.815 | 1.12 | log | |
| Odds ratio, group 1 over group 2 | 0.902 | 0.632 | 1.29 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on CPI-613, mFolfirinox than on Folfirinox | 39.3 | 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 | CPI-613, mFolfirinox | CPI-613, mFolfirinox~CPI-613 at 500 mg/m2 IV infusion at a rate of 4mL/min via a central venous port on day 1 and 3 of a 14-day cycle.~mFolfirinox (given immediately after CPI-613 administration): Oxaliplatin (Eloxatin) at 65 mg/m2 given as a 2 hr IV infusion, Folinic acid at 400 mg/m2 given as a 90 min (1.5hr) infusion immediately after Oxaliplatin, and concurrently with Irinotecan (irinotecan at 140mg/m2 given as a 90 min IV infusion) via a Y-connector, Flurouracil at 400 mg/m2 as bolus followed by a 46 hr infusion at 2400mg/m2 starting immediately after completion of folinic acid and Irinotecan.~CPI 613, mFolfirinox: CPI-613: 500mg/m2, IV infusion at a rate of 4mL/min via a central venous port.~mFolfirinox: given immediately after CPI-613 administration | 140 | 259 | EG000 |
| Group 2 | Folfirinox | Folfirinox~Folfirinox: Oxaliplatin (Eloxatin) at 85 mg/m2 given as a 2 hr IV infusion, Folinic acid at 400 mg/m2 given as a 90 min (1.5hr) infusion immediately after Oxaliplatin, and concurrently with Irinotecan (irinotecan at 180mg/m2 given as a 90 min IV infusion) via a Y-connector, Flurouracil at 400 mg/m2 as bolus followed by a 46 hr infusion at 2400mg/m2 starting immediately after completion of folinic acid and Irinotecan.~Folfirinox: Folfirinox | 133 | 235 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 38 months
Source ClinicalTrials.gov
Trial
- Title
- Study Evaluating Efficacy and Safety of FFX Versus Combination of CPI-613 With mFFX in Patients With Metastatic Adenocarcinoma of the Pancreas
- NCT number
- NCT03504423
- Phases
- PHASE3
- Conditions
- Pancreatic Cancer Metastatic
- Interventions
- CPI 613, mFolfirinox, Folfirinox
- Lead sponsor
- Cornerstone Pharmaceuticals
- Results first posted
- 2023-01-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03504423?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/NCT03504423-sae