Comparison · NCT02500043-sae
TAS-102+BSC vs Placebo+BSC: 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. TAS-102+BSC vs Placebo+BSC: serious adverse events. Trial comparisons, record NCT02500043-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02500043-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 | 0.427 | 0.375 | 0.48 | wilson | |
| Risk in group 2 | 0.417 | 0.345 | 0.492 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0102 | -0.0815 | 0.0998 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.02 | 0.824 | 1.27 | log | |
| Odds ratio, group 1 over group 2 | 1.04 | 0.716 | 1.52 | log | |
| Number needed to harm, for one more participant with a serious adverse event on TAS-102+BSC than on Placebo+BSC | 98 | 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 | TAS-102+BSC | Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met. | 143 | 335 | EG000 |
| Group 2 | Placebo+BSC | Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met. | 70 | 168 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose of study treatment up to 30 days of last study treatment (maximum duration: up to approximately 46 months).
Source ClinicalTrials.gov
Trial
- Title
- Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer
- NCT number
- NCT02500043
- Phases
- PHASE3
- Conditions
- Refractory Metastatic Gastric Cancer
- Interventions
- TAS-102, Placebo
- Lead sponsor
- Taiho Oncology, Inc.
- Results first posted
- 2021-09-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02500043?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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