Comparison · NCT01955837-sae
TAS-102 vs Placebo: 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 vs Placebo: serious adverse events. Trial comparisons, record NCT01955837-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01955837-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 | 0.232 | 0.186 | 0.286 | wilson | |
| Risk in group 2 | 0.237 | 0.173 | 0.315 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00456 | -0.0956 | 0.0789 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.981 | 0.676 | 1.42 | log | |
| Odds ratio, group 1 over group 2 | 0.975 | 0.599 | 1.59 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on TAS-102 than on Placebo | 219 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | TAS-102 | TAS-102: TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met. | 63 | 271 | EG000 |
| Group 2 | Placebo | Placebo: Placebo orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met. | 32 | 135 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Safety monitoring continued from the time a patient signed informed until 30 days after the last dose of study medication or until the initiation of another cancer therapy, whichever came first, up to 30 months.
Source ClinicalTrials.gov
Trial
- Title
- Study of Trifluridine/Tipiracil (TAS-102) in Patients With Metastatic Colorectal Cancer in Asia
- NCT number
- NCT01955837
- Phases
- PHASE3
- Conditions
- Colorectal Cancer
- Interventions
- TAS-102, Placebo
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.
- Results first posted
- 2020-11-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01955837?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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