Comparison · NCT00004054-sae
Hormones and RT vs Hormones and RT Plus Chemotherapy: 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. Hormones and RT vs Hormones and RT Plus Chemotherapy: serious adverse events. Trial comparisons, record NCT00004054-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00004054-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 | 0.0305 | 0.014 | 0.0648 | wilson | |
| Risk in group 2 | 0.35 | 0.287 | 0.418 | wilson | |
| Risk difference, group 1 minus group 2 | -0.32 | -0.39 | -0.248 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.087 | 0.0387 | 0.196 | log | |
| Odds ratio, group 1 over group 2 | 0.0583 | 0.0246 | 0.138 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Hormones and RT than on Hormones and RT Plus Chemotherapy | 3.13 | 2.57 | 4.03 | 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 | Hormones and RT | AS (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and Casodex or Eulexin). Androgen suppression will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of RT. | 6 | 197 | EG000 |
| Group 2 | Hormones and RT Plus Chemotherapy | AS (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and Casodex or Eulexin) and chemotherapy. Androgen suppression will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT. | 70 | 200 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer
- NCT number
- NCT00004054
- Phases
- PHASE3
- Conditions
- Prostate Cancer
- Interventions
- bicalutamide, estramustine phosphate sodium, etoposide, flutamide, paclitaxel, Luteinizing hormone releasing hormone [LHRH] agonist, Radiation therapy, warfarin
- Lead sponsor
- Radiation Therapy Oncology Group
- Results first posted
- 2015-01-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00004054?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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