Comparison · NCT01275677-sae
Arm I (Chemotherapy) vs Arm II (Chemotherapy, Trastuzumab): 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. Arm I (Chemotherapy) vs Arm II (Chemotherapy, Trastuzumab): serious adverse events. Trial comparisons, record NCT01275677-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01275677-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 | 0.0192 | 0.0136 | 0.0271 | wilson | |
| Risk in group 2 | 0.0591 | 0.0486 | 0.0716 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0399 | -0.0536 | -0.0268 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.325 | 0.218 | 0.484 | log | |
| Odds ratio, group 1 over group 2 | 0.312 | 0.207 | 0.47 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm I (Chemotherapy) than on Arm II (Chemotherapy, Trastuzumab) | 25.1 | 18.6 | 37.4 | 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 | Arm I (Chemotherapy) | Arm I (chemotherapy) | 31 | 1,615 | EG000 |
| Group 2 | Arm II (Chemotherapy, Trastuzumab) | Arm II (chemotherapy, trastuzumab) | 96 | 1,625 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose.
Source ClinicalTrials.gov
Trial
- Title
- Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer
- NCT number
- NCT01275677
- Phases
- PHASE3
- Conditions
HER2/Neu Positive, Progesterone Receptor Positive, Recurrent Breast Carcinoma, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7
- Interventions
- Cyclophosphamide, Docetaxel, Doxorubicin, Doxorubicin Hydrochloride, Laboratory Biomarker Analysis, Paclitaxel, Quality-of-Life Assessment, Trastuzumab
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2020-09-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01275677?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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