Comparison · NCT02178956-sae
Napabucasin + Paclitaxel vs Placebo + Paclitaxel: 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. Napabucasin + Paclitaxel vs Placebo + Paclitaxel: serious adverse events. Trial comparisons, record NCT02178956-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02178956-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 | 0.35 | 0.302 | 0.401 | wilson | |
| Risk in group 2 | 0.289 | 0.244 | 0.338 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0616 | -0.00718 | 0.129 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.21 | 0.977 | 1.51 | log | |
| Odds ratio, group 1 over group 2 | 1.33 | 0.967 | 1.82 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Napabucasin + Paclitaxel than on Placebo + Paclitaxel | 16.2 | 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 + Paclitaxel | Napabucasin was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous \[IV\]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Napabucasin administration began 2 days prior to the first paclitaxel infusion in the initial run in period. | 125 | 357 | EG000 |
| Group 2 | Placebo + Paclitaxel | Placebo was administered orally, twice daily, with doses separated by 12 hours. Paclitaxel 80 mg/m2 (intravenous \[IV\]) was administered weekly, on Days 1, 8, and 15 of each 28 day study cycle. Placebo administration began 2 days prior to the first paclitaxel infusion in the initial run in period. | 101 | 350 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse Events were collected from the time the patient signed informed consent until 30 days after the last protocol treatment administration.
Source ClinicalTrials.gov
Trial
- Title
- A Study of BBI608 Plus Weekly Paclitaxel to Treat Gastric and Gastro-Esophageal Junction Cancer
- NCT number
- NCT02178956
- Phases
- PHASE3
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer
- Interventions
- BBI608, Paclitaxel, Placebo
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Results first posted
- 2021-05-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02178956?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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