Comparison · NCT00005957-sae
Standard Breast Irradiation vs Breast Radiation Plus Regional Radiation: 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 Breast Irradiation vs Breast Radiation Plus Regional Radiation: serious adverse events. Trial comparisons, record NCT00005957-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00005957-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 | 0.00108 | 0.00019 | 0.00609 | wilson | |
| Risk in group 2 | 0.00336 | 0.00114 | 0.00983 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00228 | -0.00881 | 0.00319 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.321 | 0.0335 | 3.08 | log | |
| Odds ratio, group 1 over group 2 | 0.32 | 0.0333 | 3.09 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Standard Breast Irradiation than on Breast Radiation Plus Regional Radiation | 438 | 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 Breast Irradiation | radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.~Analysis of adverse events were based on the 927 patients who actually received Standard Breast Irradiation treatment. A total of 908 patients who were randomized to Standard Breast Irradiation and 19 patients who were randomized to Breast Radiation plus regional radiation actually received the Standard Breast Irradiation treatment. | 1 | 927 | EG000 |
| Group 2 | Breast Radiation Plus Regional Radiation | regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)~Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.~Analysis of adverse events were based on the 893 patients who actually received Breast Radiation plus regional radiation treatment. A total of 5 patients who were randomized to Standard Breast Irradiation and 888 patients who were randomized to Breast Radiation plus regional radiation actually received the Breast Radiation plus regional radiation treatment. | 3 | 893 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 10 years
Source ClinicalTrials.gov
Trial
- Title
- Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive Breast Cancer
- NCT number
- NCT00005957
- Phases
- NA
- Conditions
- Breast Cancer
- Interventions
- Standard Breast Irradiation, Breast Radiation plus Regional Radiation
- Lead sponsor
- NCIC Clinical Trials Group
- Results first posted
- 2016-06-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00005957?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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