Comparison · NCT00002651-sae
Continuous Hormonal Therapy vs Intermittent Hormonal Therapy: 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. Continuous Hormonal Therapy vs Intermittent Hormonal Therapy: serious adverse events. Trial comparisons, record NCT00002651-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00002651-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 | 0.026 | 0.0167 | 0.0402 | wilson | |
| Risk in group 2 | 0.0142 | 0.00776 | 0.026 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0117 | -0.00328 | 0.0273 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.82 | 0.853 | 3.89 | log | |
| Odds ratio, group 1 over group 2 | 1.84 | 0.851 | 3.99 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Continuous Hormonal Therapy than on Intermittent Hormonal Therapy | 85.4 | 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 | Continuous Hormonal Therapy | Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease | 19 | 732 | EG000 |
| Group 2 | Intermittent Hormonal Therapy | Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29). | 10 | 702 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 10 years after registration to Induction
Source ClinicalTrials.gov
Trial
- Title
- SWOG-9346, Hormone Therapy in Treating Men With Stage IV Prostate Cancer
- NCT number
- NCT00002651
- Phases
- PHASE3
- Conditions
- Prostate Cancer
- Interventions
- bicalutamide, goserelin acetate, clinical observation
- Lead sponsor
- SWOG Cancer Research Network
- Results first posted
- 2017-04-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00002651?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/NCT00002651-sae