Comparison · NCT01607957-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 NCT01607957-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01607957-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 | 0.296 | 0.259 | 0.337 | wilson | |
| Risk in group 2 | 0.336 | 0.282 | 0.395 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0394 | -0.109 | 0.028 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.883 | 0.713 | 1.09 | log | |
| Odds ratio, group 1 over group 2 | 0.833 | 0.608 | 1.14 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on TAS-102 than on Placebo | 25.4 | 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 | Participants received TAS-102 orally with a starting dose of 35 mg/m\^2/dose BID based on BSA along with BSC. The first dose of TAS-102 was administered in the morning of Day 1 of each cycle and the last dose was administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle = 28 days). Participants received study medication until any of the discontinuation criteria were met. | 158 | 533 | EG000 |
| Group 2 | Placebo | Participants orally received TAS-102 matching placebo BID dose along with BSC with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle). Participants received study medication until any of the discontinuation criteria. | 89 | 265 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
From the time of signing the informed consent form until the period of participant follow up (30 days following the administration of last dose of study medication or until initiation of new anti-tumor therapy, whichever was earlier, up to 85 weeks approximately (duration of study)).
Source ClinicalTrials.gov
Trial
- Title
- Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies
- NCT number
- NCT01607957
- Phases
- PHASE3
- Conditions
- Colorectal Cancer
- Interventions
- TAS-102, Placebo
- Lead sponsor
- Taiho Oncology, Inc.
- Results first posted
- 2019-05-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01607957?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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