Comparison · NCT00493870-sae
TC Arm vs TAC Arm: 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. TC Arm vs TAC Arm: serious adverse events. Trial comparisons, record NCT00493870-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00493870-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 | 0.272 | 0.245 | 0.301 | wilson | |
| Risk in group 2 | 0.342 | 0.313 | 0.372 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0695 | -0.11 | -0.0284 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.797 | 0.696 | 0.912 | log | |
| Odds ratio, group 1 over group 2 | 0.721 | 0.593 | 0.875 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on TC Arm than on TAC Arm | 14.4 | 9.06 | 35.2 | 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 | TC Arm | docetaxel 75 mg/m2 and cyclophosphamide 600 mg/m2~Docetaxel: Docetaxel 75 mg/m2 IV over 1 hour on Day 1 plus Cyclophosphamide 600 mg/m2 IV over 15-30 minutes on Day 1 Q 21 day cycles X 6. | 264 | 969 | EG000 |
| Group 2 | TAC Arm | doxorubicin 50 mg/m2, cyclophosphamide 500 mg/m2 and docetaxel 75 mg/m2~Docetaxel: Docetaxel 75 mg/m2 IV over 1 hour on Day 1 followed by cyclophosphamide~Doxorubicin: • Doxorubicin 50 mg/m2 IV push over 5-15 minutes via sidearm through a running IV line on Day 1, plus cyclophosphamide 500 mg/m2 IV over 15-30 minutes on Day 1, plus docetaxel 75 mg/m2 IV over 1 hour on Day 1, followed by pegfilgrastim 6 mg SC (or filgrastim 5 mcg/kg SC) on Day 2 Q 21 day cycles X 6. | 330 | 965 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From Baseline to 30 days after last dose of study treatment, approximately 22 weeks. All-Cause Mortality was from baseline to end of study participation, approximately 10 years.
Source ClinicalTrials.gov
Trial
- Title
- TAC Versus TC for Adjuvant Breast Cancer
- NCT number
- NCT00493870
- Phases
- PHASE3
- Conditions
- Breast Cancer
- Interventions
- Docetaxel, Doxorubicin, Cyclophosphamide
- Lead sponsor
- US Oncology Research
- Results first posted
- 2023-03-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00493870?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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