Comparison · NCT03941093-sae
Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX vs Placebo + Gemcitabine/Nab-paclitaxel or 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. Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX vs Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX: serious adverse events. Trial comparisons, record NCT03941093-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03941093-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 | 0.528 | 0.446 | 0.608 | wilson | |
| Risk in group 2 | 0.44 | 0.36 | 0.522 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0885 | -0.0277 | 0.201 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.2 | 0.942 | 1.53 | log | |
| Odds ratio, group 1 over group 2 | 1.43 | 0.893 | 2.28 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX than on Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | 11.3 | 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 | Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | Participants received pamrevlumab in combination with one chemotherapy treatment regimen (gemcitabine plus nab-paclitaxel or FOLFIRINOX) over a 28-day cycle, for up to 6 cycles. Pamrevlumab was administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion. Nab-paclitaxel was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. Gemcitabine was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. FOLFIRINOX was a combination of several agents administered on Days 1 and 15 of each 28-day treatment cycle via IV infusion. The specific agents were oxaliplatin, folinic acid, irinotecan, and fluorouracil. | 75 | 142 | EG000 |
| Group 2 | Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX | Participants received pamrevlumab matched placebo in combination with one chemotherapy treatment regimen (gemcitabine plus nab-paclitaxel or FOLFIRINOX) over a 28-day cycle, for up to 6 cycles. Placebo was administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion. Nab-paclitaxel was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. Gemcitabine was administered on Days 1, 8 and 15 of each 28-day treatment cycle via IV infusion. FOLFIRINOX was a combination of several agents administered on Days 1 and 15 of each 28-day treatment cycle via IV infusion. The specific agents were oxaliplatin, folinic acid, irinotecan, and fluorouracil. | 62 | 141 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to approximately 5 years
Source ClinicalTrials.gov
Trial
- Title
Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX) in Participants With Locally Advanced, Unresectable Pancreatic Cancer
- NCT number
- NCT03941093
- Phases
- PHASE3
- Conditions
- Pancreatic Cancer Non-resectable
- Interventions
- Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX, Placebo + Gemcitabine + Nab-paclitaxel or Placebo + FOLFIRINOX
- Lead sponsor
- Kyntra Bio
- Results first posted
- 2024-11-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03941093?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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