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Comparison · NCT00087178-sae

Adriamycin + Cyclophosphamide vs Fluorouracil + Epirubicin + Cyclophosphamide: serious adverse events

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. Adriamycin + Cyclophosphamide vs Fluorouracil + Epirubicin + Cyclophosphamide: serious adverse events. Trial comparisons, record NCT00087178-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00087178-sae

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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 10.008880.005090.0155wilson
Risk in group 20.01940.01330.0283wilson
Risk difference, group 1 minus group 2-0.0106-0.0202-0.00156newcombe hybrid score
Risk ratio, group 1 over group 20.4570.2310.901log
Odds ratio, group 1 over group 20.4520.2270.899log
Number needed to treat, for one fewer participant with a serious adverse event on Adriamycin + Cyclophosphamide than on Fluorouracil + Epirubicin + Cyclophosphamide94.749.4639from the risk difference interval

Groups2

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

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Adriamycin + Cyclophosphamide
Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses.~cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles~adriamycin: adriamycin 60 mg/m2 IV every 21 days for 4 cycles
121,351EG000
Group 2Fluorouracil + Epirubicin + Cyclophosphamide
Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.~cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles~epirubicin: epirubicin 100 mg/m2 IV every 21 days for 6 cycles~fluorouracil: fluorouracil 500 mg/m2 IV every 21 days for 6 cycles
261,337EG001

Harm

What it counts
Total, serious adverse events
Time frame

Source ClinicalTrials.gov

Trial

Title
Comparison of Two Combination Chemotherapy Regimens in Treating Women With Breast Cancer
NCT number
NCT00087178
Phases
PHASE3
Conditions
Breast Cancer
Interventions
cyclophosphamide, adriamycin, epirubicin, fluorouracil
Lead sponsor
NSABP Foundation Inc
Results first posted
2022-08-11

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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