Comparison · NCT02993731-0dc08574
Napabucasin Plus Nab-paclitaxel With Gemcitabine (Safety Population) vs Nab-paclitaxel With Gemcitabine (Safety Population): Number of Patients With 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. Napabucasin Plus Nab-paclitaxel With Gemcitabine (Safety Population) vs Nab-paclitaxel With Gemcitabine (Safety Population): Number of Patients With Adverse Events. Trial comparisons, record NCT02993731-0dc08574. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02993731-0dc08574
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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 | 0.998 | 0.99 | 1 | wilson | |
| Risk in group 2 | 0.993 | 0.981 | 0.997 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00553 | -0.00385 | 0.017 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.01 | 0.998 | 1.01 | log | |
| Odds ratio, group 1 over group 2 | 4.13 | 0.46 | 37 | log | |
| Number needed to treat, for one more participant with the outcome on Napabucasin Plus Nab-paclitaxel With Gemcitabine (Safety Population) than on Nab-paclitaxel With Gemcitabine (Safety Population) | 181 | 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 | Napabucasin Plus Nab-paclitaxel With Gemcitabine (Safety Population) | All participants who received at least 1 dose of napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks. | 560 | 561 | OG000 |
| Group 2 | Nab-paclitaxel With Gemcitabine (Safety Population) | All participants who received at least 1 dose of nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks. | 543 | 547 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Patients With Adverse Events
- Description
All patients who have received at least one dose of napabucasin will be included in the safety analysis according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.0. The incidence of adverse events will be summarized by type of adverse event and severity.
- Time frame
Every 1-2 weeks from date of screening until protocol treatment discontinuation. Following permanent protocol treatment discontinuation, every 8 weeks, starting with the 4 week post-protocol treatment discontinuation visit, up to 36 months.
- Population
Source ClinicalTrials.gov
Trial
- Title
- A Study of Napabucasin Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma
- NCT number
- NCT02993731
- Phases
- PHASE3
- Conditions
- Carcinoma, Pancreatic Ductal
- Interventions
- Napabucasin, Nab-paclitaxel, Gemcitabine
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Results first posted
- 2021-06-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02993731?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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