Comparison · NCT04163900-sae
A - NUC-1031 and Cisplatin vs B - Gemcitabine and Cisplatin: 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. A - NUC-1031 and Cisplatin vs B - Gemcitabine and Cisplatin: serious adverse events. Trial comparisons, record NCT04163900-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04163900-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 | 0.457 | 0.408 | 0.507 | wilson | |
| Risk in group 2 | 0.333 | 0.288 | 0.382 | wilson | |
| Risk difference, group 1 minus group 2 | 0.124 | 0.0541 | 0.191 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.37 | 1.15 | 1.64 | log | |
| Odds ratio, group 1 over group 2 | 1.68 | 1.25 | 2.26 | log | |
| Number needed to harm, for one more participant with a serious adverse event on A - NUC-1031 and Cisplatin than on B - Gemcitabine and Cisplatin | 8.09 | 5.23 | 18.5 | from the risk difference interval |
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 | A - NUC-1031 and Cisplatin | 725 mg/m\^2 NUC-1031 administered in combination with 25 mg/m\^2 cisplatin on Days 1 and 8 of a 21-day cycle~NUC-1031: IV infusion in 500 mL of 0.9% sterile saline for injection given over 30 minutes~Cisplatin: IV in accordance with local institutional practice for biliary tract cancer, including the use of an appropriate hydration protocol | 175 | 383 | EG000 |
| Group 2 | B - Gemcitabine and Cisplatin | 1000 mg/m\^2 gemcitabine administered in combination with 25 mg/m\^2 cisplatin on Days 1 and 8 of a 21-day cycle~Gemcitabine: IV infusion in 250 mL of 0.9% sterile saline for injection given in accordance with the package insert~Cisplatin: IV in accordance with local institutional practice for biliary tract cancer, including the use of an appropriate hydration protocol | 126 | 378 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months
Source ClinicalTrials.gov
Trial
- Title
- Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract Cancer
- NCT number
- NCT04163900
- Phases
- PHASE3
- Conditions
- Biliary Tract Cancer
- Interventions
- NUC-1031, Gemcitabine, Cisplatin
- Lead sponsor
- NuCana plc
- Results first posted
- 2023-05-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04163900?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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