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Comparison · NCT00129389-deaths

Arm A: FAC vs Arm B: FAC-wP: 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: FAC vs Arm B: FAC-wP: deaths from any cause. Trial comparisons, record NCT00129389-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00129389-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 10.04110.03030.0554wilson
Risk in group 20.03260.02310.0459wilson
Risk difference, group 1 minus group 20.00847-0.008640.0257newcombe hybrid score
Risk ratio, group 1 over group 21.260.7952log
Odds ratio, group 1 over group 21.270.7882.05log
Number needed to harm, for one more death from any cause on Arm A: FAC than on Arm B: FAC-wP118from 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: FACFAC X 6 The standard arm consisted of six cycles of FAC (fluorouracil 500 mg/m2, doxorubicin 50mg/m2, and cyclophosphamide 500mg/m2) administered once every 3 weeks.40974EG000
Group 2Arm B: FAC-wPFAC X 4 + 8 weekly Paclitaxel (wP) Patients in the experimental arm received four cycles of the FAC regimen followed by eight weekly administrations of paclitaxel (100mg/m2 per dose)31951EG001

Harm

What it counts
Total, all-cause mortality
Time frame
Through study treatment up to 30 days after last study dose; All-Cause Mortality was assessed up to 5 years.

Source ClinicalTrials.gov

Trial

Title
FAC Versus FAC Plus Weekly Paclitaxel as Adjuvant Treatment of Node Negative High Risk Breast Cancer Patients
NCT number
NCT00129389
Phases
PHASE3
Conditions
Breast Cancer
Interventions
Fluorouracil, Doxorubicin, Cyclophosphamide, Paclitaxel
Lead sponsor
Spanish Breast Cancer Research Group
Results first posted
2019-07-12

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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