Comparison · NCT04083235-sae
NALIRIFOX vs Nab-paclitaxel+Gemcitabine: 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. NALIRIFOX vs Nab-paclitaxel+Gemcitabine: serious adverse events. Trial comparisons, record NCT04083235-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04083235-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 | 0.559 | 0.509 | 0.609 | wilson | |
| Risk in group 2 | 0.522 | 0.472 | 0.572 | wilson | |
| Risk difference, group 1 minus group 2 | 0.037 | -0.0342 | 0.108 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.07 | 0.938 | 1.22 | log | |
| Odds ratio, group 1 over group 2 | 1.16 | 0.871 | 1.55 | log | |
| Number needed to harm, for one more participant with a serious adverse event on NALIRIFOX than on Nab-paclitaxel+Gemcitabine | 27 | 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 | NALIRIFOX | Participants were treated with irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2, followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent. | 207 | 370 | EG000 |
| Group 2 | Nab-paclitaxel+Gemcitabine | Participants were treated with nab-paclitaxel 125 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent. | 198 | 379 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Treatment-emergent serious adverse events (TESAEs) and non-serious TEAEs were collected from the start of study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 1530 days. All-cause mortality (death) was assessed from signing of the informed consent form till end of follow up per participant, approximately 1834 days.
Source ClinicalTrials.gov
Trial
- Title
A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment
- NCT number
- NCT04083235
- Phases
- PHASE3
- Conditions
- Metastatic Adenocarcinoma of the Pancreas
- Interventions
- Irinotecan Liposomal Injection, Oxaliplatin, 5Fluorouracil, Leucovorin, Nab-paclitaxel, Gemcitabine
- Lead sponsor
- Ipsen
- Results first posted
- 2024-03-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04083235?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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