Comparison · NCT01272037-sae
Chemo and Endocrine Therapy vs Endocrine Therapy Alone: 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. Chemo and Endocrine Therapy vs Endocrine Therapy Alone: serious adverse events. Trial comparisons, record NCT01272037-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01272037-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 | 0.00679 | 0.00405 | 0.0114 | wilson | |
| Risk in group 2 | 0.00384 | 0.00202 | 0.00729 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00295 | -0.00146 | 0.00787 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.77 | 0.766 | 4.07 | log | |
| Odds ratio, group 1 over group 2 | 1.77 | 0.765 | 4.1 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Chemo and Endocrine Therapy than on Endocrine Therapy Alone | 339 | 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 | Chemo and Endocrine Therapy | Participants receive a protocol-approved chemotherapy regimen based on the participant and/or physician preference. Participants then receive a protocol-approved adjuvant endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity. | 14 | 2,062 | EG000 |
| Group 2 | Endocrine Therapy Alone | Participants receive a protocol-approved endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity. | 9 | 2,342 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Source ClinicalTrials.gov
Trial
- Title
- Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer
- NCT number
- NCT01272037
- Phases
- PHASE3
- Conditions
- Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma, Multicentric Breast Carcinoma, Multifocal Breast Carcinoma, Synchronous Bilateral Breast Carcinoma
- Interventions
- Anastrozole, Exemestane, Laboratory Biomarker Analysis, Letrozole, Quality-of-Life Assessment, Systemic Chemotherapy, Tamoxifen Citrate
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2023-06-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01272037?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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