Comparison · NCT03665441-sae
Eryaspase Plus Chemotherapy vs Chemotherapy Alone: 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. Eryaspase Plus Chemotherapy vs Chemotherapy Alone: serious adverse events. Trial comparisons, record NCT03665441-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03665441-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 | 0.492 | 0.43 | 0.554 | wilson | |
| Risk in group 2 | 0.427 | 0.367 | 0.489 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0651 | -0.0226 | 0.151 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.15 | 0.951 | 1.4 | log | |
| Odds ratio, group 1 over group 2 | 1.3 | 0.912 | 1.85 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Eryaspase Plus Chemotherapy than on Chemotherapy Alone | 15.4 | 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 | Eryaspase Plus Chemotherapy | eryaspase 100 U/kg dosed every 2 weeks in combination with~Gemcitabine plus abraxane (albumin-bound paclitaxel) administered on Days 1, 8, and 15 of each 4 week cycle as follows:~* Abraxane (125 mg/m2) IV~* Gemcitabine (1000 mg/m2) IV~Or~Irinotecan plus 5-FU plus leucovorin administered on Days 1 and 15 of each 4 week cycle as follows:~* Onivyde 70 mg/m2 (irinotecan freebase) IV (recommended dose in patients homozygous for UGT1A1\*28 is 50 mg/m2)~* Leucovorin 400 mg/m2 IV~* 5 FU 2400 mg/m2~Or~* FOLFIRI: Irinotecan 180 mg/m2 IV~* Leucovorin 400 mg/m² IV~* 5 FU 400 mg/m² IV bolus~* 5 FU 2400 mg/m² IV continuous infusion over 46 hours immediately following bolus 5 FU~eryaspase: L-asparaginase encapsulated in erythrocytes (red blood cells)~Gemcitabine plus Abraxane: gemcitabine, Abraxane~Irinotecan plus 5-FU plus leucovorin: irinotecan, 5-FU, leucovorin | 122 | 248 | EG000 |
| Group 2 | Chemotherapy Alone | Standard treatment: Gemcitabine plus abraxane (albumin-bound paclitaxel) administered on Days 1, 8, and 15 of each 4 week cycle Or Irinotecan plus 5-FU plus leucovorin administered on Days 1 and 15 of each 4 week cycle~Gemcitabine plus Abraxane: gemcitabine, Abraxane~Irinotecan plus 5-FU plus leucovorin: irinotecan, 5-FU, leucovorin | 105 | 246 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 9 months (Adverse events were monitored for approximately 9 months and mortality assessed for approximately 12 months.)
Source ClinicalTrials.gov
Trial
- Title
- Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment in PAC
- NCT number
- NCT03665441
- Phases
- PHASE3
- Conditions
- Pancreatic Adenocarcinoma
- Interventions
- eryaspase, Gemcitabine plus Abraxane, Irinotecan plus 5-FU plus leucovorin
- Lead sponsor
- ERYtech Pharma
- Results first posted
- 2022-09-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03665441?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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