Comparison · NCT00129389-sae
Arm A: FAC vs Arm B: FAC-wP: 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. Arm A: FAC vs Arm B: FAC-wP: serious adverse events. Trial comparisons, record NCT00129389-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00129389-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 | 0.0616 | 0.0482 | 0.0785 | wilson | |
| Risk in group 2 | 0.0641 | 0.0503 | 0.0815 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00254 | -0.0245 | 0.0193 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.96 | 0.68 | 1.36 | log | |
| Odds ratio, group 1 over group 2 | 0.958 | 0.663 | 1.38 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm A: FAC than on Arm B: FAC-wP | 393 | 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 | Arm A: FAC | FAC 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. | 60 | 974 | EG000 |
| Group 2 | Arm B: FAC-wP | FAC 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) | 61 | 951 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- 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
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00129389?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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