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Comparison · NCT02753127-deaths

Napabucasin + FOLFIRI ± Bevacizumab vs FOLFIRI ± Bevacizumab: deaths from any cause

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Napabucasin + FOLFIRI ± Bevacizumab vs FOLFIRI ± Bevacizumab: deaths from any cause. Trial comparisons, record NCT02753127-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02753127-deaths

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.8130.780.841wilson
Risk in group 20.7930.760.823wilson
Risk difference, group 1 minus group 20.0192-0.02490.0632newcombe hybrid score
Risk ratio, group 1 over group 21.020.9691.08log
Odds ratio, group 1 over group 21.130.8541.49log
Number needed to harm, for one more death from any cause on Napabucasin + FOLFIRI ± Bevacizumab than on FOLFIRI ± Bevacizumab52.1from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Napabucasin + FOLFIRI ± Bevacizumab
All patients who received at least 1 dose of study drug (BBI-608 and/or FOLFIRI) with treatment assignment designated according to the actual study treatment received. Napabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 12 hours (480 mg total daily dose).~Addition of bevacizumab to the FOLFIRI regimen will be permissible. FOLFIRI chemotherapy infusion will start at least 2 hours following the first daily dose of napabucasin and will be administered every 2 weeks. Irinotecan/leucovorin infusion will follow bevacizumab infusion in selected patients to receive standard dose of bevacizumab (5 mg/kg). This regimen will be repeated on Day 1 of every 14 day cycle.
507624EG000
Group 2FOLFIRI ± Bevacizumab
All patients who received at least 1 dose of study drug (BBI-608 and/or FOLFIRI) with treatment assignment designated according to the actual study treatment received. Addition of bevacizumab to the FOLFIRI regimen will be permissible. FOLFIRI chemotherapy infusion will be administered every 2 weeks. Irinotecan/leucovorin infusion will follow bevacizumab infusion in selected patients to receive standard dose of bevacizumab (5 mg/kg). This regimen will be repeated on Day 1 of every 14 day cycle.
499629EG001

Harm

What it counts
Total, all-cause mortality
Time frame
All adverse event are collected from date of signed informed consent until 30 days after protocol treatment discontinuation. Outcome followed until study discontinuation.

Source ClinicalTrials.gov

Trial

Title
A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer
NCT number
NCT02753127
Phases
PHASE3
Conditions
Colorectal Cancer
Interventions
Napabucasin, Fluorouracil, Leucovorin, Irinotecan, Bevacizumab
Lead sponsor
Sumitomo Pharma America, Inc.
Results first posted
2022-04-26

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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