Comparison · NCT02855125-sae
TAS-114 + S-1 vs S-1 (Monotherapy): 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-114 + S-1 vs S-1 (Monotherapy): serious adverse events. Trial comparisons, record NCT02855125-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02855125-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 | 0.469 | 0.352 | 0.589 | wilson | |
| Risk in group 2 | 0.302 | 0.202 | 0.424 | wilson | |
| Risk difference, group 1 minus group 2 | 0.167 | -0.00188 | 0.323 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.55 | 0.984 | 2.46 | log | |
| Odds ratio, group 1 over group 2 | 2.04 | 0.986 | 4.23 | log | |
| Number needed to harm, for one more participant with a serious adverse event on TAS-114 + S-1 than on S-1 (Monotherapy) | 5.98 | 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-114 + S-1 | Participants received 400 mg of TAS-114 tablets orally BID along with 30 mg/m\^2 of S-1 capsule BID for 2 weeks (Day 1 to 14), followed by 1 week recovery period (Day 15 to 21) in each 21 days cycle, until progressive disease (PD), occurrence of intolerable side effects, removal by the Investigator, or withdrawal of consent (maximum treatment duration: 51 weeks). | 30 | 64 | EG000 |
| Group 2 | S-1 (Monotherapy) | Participants received 30 mg/m\^2 of S-1 capsules BID for 2 weeks (Day 1 to 14) followed by 1 week recovery period (Day 15 to 21) in each 21 days cycle, until progressive disease (PD), occurrence of intolerable side effects, removal by the Investigator, or withdrawal of consent (maximum treatment duration: 38 weeks). | 19 | 63 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose of study drug up to 30 days after the last dose of study drug (approximately up to 13 months)
Source ClinicalTrials.gov
Trial
- Title
- A Randomized Phase 2 Trial of TAS-114 in Combination With S-1 Versus S-1
- NCT number
- NCT02855125
- Phases
- PHASE2
- Conditions
- Advanced or Metastatic Non-small Cell Lung Cancer
- Interventions
- TAS-114, S-1
- Lead sponsor
- Taiho Oncology, Inc.
- Results first posted
- 2021-12-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02855125?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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