Comparison · NCT02311933-sae
Arm I (Z-endoxifen Hydrochloride) vs Arm II (Tamoxifen Citrate): 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. Arm I (Z-endoxifen Hydrochloride) vs Arm II (Tamoxifen Citrate): serious adverse events. Trial comparisons, record NCT02311933-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02311933-sae
On this page
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 | 0.195 | 0.102 | 0.34 | wilson | |
| Risk in group 2 | 0.282 | 0.165 | 0.438 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0869 | -0.268 | 0.0992 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.692 | 0.311 | 1.54 | log | |
| Odds ratio, group 1 over group 2 | 0.617 | 0.218 | 1.75 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm I (Z-endoxifen Hydrochloride) than on Arm II (Tamoxifen Citrate) | 11.5 | 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 | Arm I (Z-endoxifen Hydrochloride) | Patients receive 80 mg z-endoxifen hydrochloride PO on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. | 8 | 41 | EG000 |
| Group 2 | Arm II (Tamoxifen Citrate) | Patients receive 20 mg tamoxifen citrate PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression and bone metastases may cross over to Arm I and receive z-endoxifen hydrochloride starting no later than 28 days after documentation of disease progression. | 11 | 39 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected at the end of every 3 week cycle (up to a max 92 cycles). The data reported here for the primary submission is through 8/18/2021.
Source ClinicalTrials.gov
Trial
- Title
- Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
- NCT number
- NCT02311933
- Phases
- PHASE2
- Conditions
- Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7, Stage IV Breast Cancer AJCC v6 and v7
- Interventions
- Endoxifen Hydrochloride, Laboratory Biomarker Analysis, Pharmacological Study, Tamoxifen Citrate
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2021-09-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02311933?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT02311933-sae