Comparison · NCT02562716-sae
mFOLFIRINOX->Surg->mFOLFIRINOX vs Gem/Nab-P->Surg->Gem/Nab-P: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. mFOLFIRINOX->Surg->mFOLFIRINOX vs Gem/Nab-P->Surg->Gem/Nab-P: serious adverse events. Trial comparisons, record NCT02562716-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02562716-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 | 0.0566 | 0.0194 | 0.154 | wilson | |
| Risk in group 2 | 0.111 | 0.0484 | 0.235 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0545 | -0.184 | 0.0611 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.509 | 0.129 | 2.02 | log | |
| Odds ratio, group 1 over group 2 | 0.48 | 0.108 | 2.13 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on mFOLFIRINOX->Surg->mFOLFIRINOX than on Gem/Nab-P->Surg->Gem/Nab-P | 18.3 | 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 | mFOLFIRINOX->Surg->mFOLFIRINOX | Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity.~Participants who received at least one dose of protocol treatment and were thus eligible for AE assessment are included in the Serious Adverse Events and Other Adverse Events tables. All eligible participants were assessed for All-Cause Mortality. | 3 | 53 | EG000 |
| Group 2 | Gem/Nab-P->Surg->Gem/Nab-P | Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.~Participants who received at least one dose of protocol treatment and were thus eligible for AE assessment are included in the Serious Adverse Events and Other Adverse Events tables. All eligible participants were assessed for All-Cause Mortality. | 5 | 45 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Duration of treatment and follow up until death or 4 years post registration.
Source ClinicalTrials.gov
Trial
- Title
S1505: Combination Chemotherapy or Gemcitabine Hydrochloride and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
- NCT number
- NCT02562716
- Phases
- PHASE2
- Conditions
- Pancreatic Adenocarcinoma, Resectable Pancreatic Carcinoma
- Interventions
- Fluorouracil, Gemcitabine Hydrochloride, Irinotecan Hydrochloride, Oxaliplatin, Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Pancreatectomy
- Lead sponsor
- SWOG Cancer Research Network
- Results first posted
- 2021-07-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02562716?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
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GET https://conductscience.org/api/comparisons/v1/NCT02562716-sae