Comparison · NCT00688740-sae
TAC (Docetaxel) vs FAC (5-fluorouracil): 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. TAC (Docetaxel) vs FAC (5-fluorouracil): serious adverse events. Trial comparisons, record NCT00688740-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00688740-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 | 0.359 | 0.325 | 0.394 | wilson | |
| Risk in group 2 | 0.091 | 0.0723 | 0.114 | wilson | |
| Risk difference, group 1 minus group 2 | 0.268 | 0.227 | 0.308 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.94 | 3.08 | 5.05 | log | |
| Odds ratio, group 1 over group 2 | 5.59 | 4.17 | 7.49 | log | |
| Number needed to harm, for one more participant with a serious adverse event on TAC (Docetaxel) than on FAC (5-fluorouracil) | 3.73 | 3.25 | 4.4 | from the risk difference interval |
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 | TAC (Docetaxel) | docetaxel in combination with doxorubicin and cyclophosphamide | 267 | 744 | EG000 |
| Group 2 | FAC (5-fluorouracil) | 5-fluorouracil in combination with doxorubicin and cyclophosphamide | 67 | 736 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- from date of randomization until the completion of the 10-year follow-up period.
Source ClinicalTrials.gov
Trial
- Title
- Docetaxel in Node Positive Adjuvant Breast Cancer
- NCT number
- NCT00688740
- Phases
- PHASE3
- Conditions
- Breast Cancer
- Interventions
- Docetaxel, 5-fluorouracil, Doxorubicin, Cyclophosphamide
- Lead sponsor
- Sanofi
- Results first posted
- 2011-02-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00688740?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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