Comparison · NCT00002597-sae
Neoadjuvant TAS 2 Months Before and During RT vs Radiation 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. Neoadjuvant TAS 2 Months Before and During RT vs Radiation Therapy Alone: serious adverse events. Trial comparisons, record NCT00002597-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00002597-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 | 0.0329 | 0.0235 | 0.0458 | wilson | |
| Risk in group 2 | 0.016 | 0.00984 | 0.0258 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0169 | 0.00338 | 0.0313 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.06 | 1.14 | 3.72 | log | |
| Odds ratio, group 1 over group 2 | 2.1 | 1.15 | 3.84 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Neoadjuvant TAS 2 Months Before and During RT than on Radiation Therapy Alone | 59 | 32 | 296 | 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 | Neoadjuvant TAS 2 Months Before and During RT | Neoadjuvant Total Androgen Suppression (TAS) two months before and during radiation therapy | 33 | 1,003 | EG000 |
| Group 2 | Radiation Therapy Alone | Radiation therapy alone | 16 | 1,003 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer
- NCT number
- NCT00002597
- Phases
- PHASE3
- Conditions
- Prostate Cancer
- Interventions
- flutamide, Zoladex, Lupron, radiation therapy
- Lead sponsor
- Radiation Therapy Oncology Group
- Results first posted
- 2017-06-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00002597?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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