Comparison · NCT04737187-sae
Trifluridine/Tipiracil + Bevacizumab vs Trifluridine/Tipiracil: 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. Trifluridine/Tipiracil + Bevacizumab vs Trifluridine/Tipiracil: serious adverse events. Trial comparisons, record NCT04737187-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04737187-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 | 0.268 | 0.217 | 0.327 | wilson | |
| Risk in group 2 | 0.321 | 0.266 | 0.382 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0528 | -0.132 | 0.0277 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.835 | 0.635 | 1.1 | log | |
| Odds ratio, group 1 over group 2 | 0.775 | 0.525 | 1.14 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Trifluridine/Tipiracil + Bevacizumab than on Trifluridine/Tipiracil | 18.9 | 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 | Trifluridine/Tipiracil + Bevacizumab | Participants were administered 35 mg/m²/dose FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest; with bevacizumab 5 mg/kg, IV infusion administered every 2 weeks (Day 1 and Day 15). This treatment cycle was repeated every 4 weeks. | 66 | 246 | EG000 |
| Group 2 | Trifluridine/Tipiracil | Participants were administered 35 mg/m²/dose of FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest. This treatment cycle was repeated every 4 weeks. | 79 | 246 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Serious AEs and Other AEs: From baseline (Cycle 1 Day 1) up to 30 days after the last dose of study drug (i.e., up to 30.7 months); All-cause mortality: from baseline (Cycle 1 Day 1) up to end of the study (i.e., up to 33.6 months)
Source ClinicalTrials.gov
Trial
- Title
- Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients
- NCT number
- NCT04737187
- Phases
- PHASE3
- Conditions
- Refractory Metastatic Colorectal Cancer
- Interventions
- Trifluridine/Tipiracil, Bevacizumab
- Lead sponsor
- Taiho Oncology, Inc.
- Results first posted
- 2023-12-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04737187?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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