Comparison · NCT03943667-sae
GEMPAX vs Control: 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. GEMPAX vs Control: serious adverse events. Trial comparisons, record NCT03943667-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03943667-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 | 0.507 | 0.425 | 0.589 | wilson | |
| Risk in group 2 | 0.366 | 0.264 | 0.482 | wilson | |
| Risk difference, group 1 minus group 2 | 0.141 | -0.00124 | 0.272 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.38 | 0.979 | 1.96 | log | |
| Odds ratio, group 1 over group 2 | 1.78 | 0.992 | 3.2 | log | |
| Number needed to harm, for one more participant with a serious adverse event on GEMPAX than on Control | 7.09 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | GEMPAX | Gemcitabine + Paclitaxel until progression~Gemcitabine: 1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.~Paclitaxel: 80 mg/m² in IV infusion over 60 minutes at Day 1, 8 and 15 followed by 1 week of rest. | 71 | 140 | EG000 |
| Group 2 | Control | Gemcitabine alone until progression~Gemcitabine: 1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest. | 26 | 71 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
GEMPAX tracks adverse events for each participant from their first treatment dose, at day 1, day 8 and day 15 of each treatment cycle, and up to 30 days after the day of last treatment dose, approximatively 7 months.
Source ClinicalTrials.gov
Trial
- Title
- Gemcitabine and Paclitaxel vs Gemcitabine Alone After FOLFIRINOX Failure in Metastatic Pancreatic Ductal Adenocarcinoma
- NCT number
- NCT03943667
- Phases
- PHASE3
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Interventions
- Gemcitabine, Paclitaxel
- Lead sponsor
- UNICANCER
- Results first posted
- 2026-01-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03943667?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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