Comparison · NCT00338286-sae
Standard Supportive Care (SOC) vs Epoetin Alfa: 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. Standard Supportive Care (SOC) vs Epoetin Alfa: serious adverse events. Trial comparisons, record NCT00338286-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00338286-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 | 0.219 | 0.195 | 0.245 | wilson | |
| Risk in group 2 | 0.239 | 0.214 | 0.266 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0197 | -0.0556 | 0.0163 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.918 | 0.784 | 1.07 | log | |
| Odds ratio, group 1 over group 2 | 0.894 | 0.729 | 1.1 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Standard Supportive Care (SOC) than on Epoetin Alfa | 50.8 | 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 | Standard Supportive Care (SOC) | Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion | 229 | 1,045 | EG000 |
| Group 2 | Epoetin Alfa | Participants received SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week. | 251 | 1,051 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From randomization up to 8.4 years
Source ClinicalTrials.gov
Trial
- Title
- A Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy
- NCT number
- NCT00338286
- Phases
- PHASE3
- Conditions
- Breast Cancer, Neoplasm Metastasis
- Interventions
- Standard supportive care (packed RBC transfusion), epoetin alfa + packed RBC transfusion
- Lead sponsor
- Janssen Research & Development, LLC
- Results first posted
- 2016-03-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00338286?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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