Comparison · NCT02923921-sae
Pegilodecakin + FOLFOX vs FOLFOX: 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. Pegilodecakin + FOLFOX vs FOLFOX: serious adverse events. Trial comparisons, record NCT02923921-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02923921-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 | 0.442 | 0.385 | 0.501 | wilson | |
| Risk in group 2 | 0.378 | 0.321 | 0.44 | wilson | |
| Risk difference, group 1 minus group 2 | 0.064 | -0.02 | 0.146 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.17 | 0.951 | 1.44 | log | |
| Odds ratio, group 1 over group 2 | 1.3 | 0.92 | 1.85 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Pegilodecakin + FOLFOX than on FOLFOX | 15.6 | 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 | Pegilodecakin + FOLFOX | Pegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 mg for participants weighing ≤80 kg or 0.8 mg for participants weighing\>80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX \[dl-Leucovorin (dl-LV) 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2\] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression \[that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity\], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing\>80 kg. | 123 | 278 | EG000 |
| Group 2 | FOLFOX | FOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5- FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. | 95 | 251 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline Up To 36 Months
Source ClinicalTrials.gov
Trial
- Title
- Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer
- NCT number
- NCT02923921
- Phases
- PHASE3
- Conditions
- Pancreatic Cancer
- Interventions
- Pegilodecakin, FOLFOX
- Lead sponsor
- Eli Lilly and Company
- Results first posted
- 2020-10-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02923921?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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