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Comparison · NCT01298570-deaths

Arm A vs Arm B: 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. Arm A vs Arm B: deaths from any cause. Trial comparisons, record NCT01298570-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01298570-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 10.9330.8740.966wilson
Risk in group 20.9670.8880.991wilson
Risk difference, group 1 minus group 2-0.0339-0.09780.0516newcombe hybrid score
Risk ratio, group 1 over group 20.9650.9031.03log
Odds ratio, group 1 over group 20.4750.09762.31log
Number needed to treat, for one fewer death from any cause on Arm A than on Arm B29.5from 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 1Arm A
regorafenib 160 mg + FOLFIRI~Regorafenib (BAY 73-4506): Regorafenib, 160 mg, PO, daily, per 7 day cycle~FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle.
112120EG000
Group 2Arm B
Placebo + FOLFIRI~Placebo: Placebo, oral administration, Days 4-10 and Days 18-24 of 28 day cycle +~FOLFIRI: FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle.
5961EG001

Harm

What it counts
Total, all-cause mortality
Time frame

Source ClinicalTrials.gov

Trial

Title
Regorafenib+FOLFIRI Versus Placebo+FOLFIRI as 2nd Line Tx in Metastatic Colorectal Cancer
NCT number
NCT01298570
Phases
PHASE2
Conditions
Colorectal Cancer Metastatic
Interventions
Regorafenib (BAY 73-4506), FOLFIRI, Placebo, FOLFIRI
Lead sponsor
UNC Lineberger Comprehensive Cancer Center
Results first posted
2018-02-28

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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