Comparison · NCT00601900-sae
Arm I (Endocrine Therapy With Monoclonal Antibody) vs Arm II (Endocrine Therapy): 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 (Endocrine Therapy With Monoclonal Antibody) vs Arm II (Endocrine Therapy): serious adverse events. Trial comparisons, record NCT00601900-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00601900-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 | 0.287 | 0.228 | 0.354 | wilson | |
| Risk in group 2 | 0.153 | 0.109 | 0.21 | wilson | |
| Risk difference, group 1 minus group 2 | 0.134 | 0.0521 | 0.214 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.88 | 1.26 | 2.79 | log | |
| Odds ratio, group 1 over group 2 | 2.23 | 1.36 | 3.67 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm I (Endocrine Therapy With Monoclonal Antibody) than on Arm II (Endocrine Therapy) | 7.46 | 4.67 | 19.2 | 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 | Arm I (Endocrine Therapy With Monoclonal Antibody) | Patients receive endocrine therapy\* (tamoxifen citrate\* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. | 56 | 195 | EG000 |
| Group 2 | Arm II (Endocrine Therapy) | Patients receive endocrine therapy\* (tamoxifen citrate\* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. | 30 | 196 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All patients that received study treatment and were analyzed for adverse events are included in this summary.
Source ClinicalTrials.gov
Trial
- Title
- Tamoxifen Citrate or Letrozole With or Without Bevacizumab in Treating Women With Stage IIIB or Stage IV Breast Cancer
- NCT number
- NCT00601900
- Phases
- PHASE3
- Conditions
- Invasive Breast Carcinoma, Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v6, Stage IV Breast Cancer AJCC v6 and v7
- Interventions
- Bevacizumab, Laboratory Biomarker Analysis, Letrozole, Questionnaire Administration, Tamoxifen Citrate
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2016-08-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00601900?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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