Comparison · NCT00134056-sae
Arm II: Atrasentan vs Arm I: Placebo: 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. Arm II: Atrasentan vs Arm I: Placebo: serious adverse events. Trial comparisons, record NCT00134056-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00134056-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 | 0.311 | 0.272 | 0.353 | wilson | |
| Risk in group 2 | 0.354 | 0.313 | 0.397 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0429 | -0.102 | 0.0161 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.879 | 0.735 | 1.05 | log | |
| Odds ratio, group 1 over group 2 | 0.824 | 0.631 | 1.08 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm II: Atrasentan than on Arm I: Placebo | 23.3 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Arm II: Atrasentan | Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks. | 153 | 492 | EG001 |
| Group 2 | Arm I: Placebo | Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks. | 172 | 486 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Assessed every 3 weeks up to 52 weeks
Source ClinicalTrials.gov
Trial
- Title
- S0421, Docetaxel and Prednisone With or Without Atrasentan in Treating Patients With Stage IV Prostate Cancer and Bone Metastases That Did Not Respond to Previous Hormone Therapy
- NCT number
- NCT00134056
- Phases
- PHASE3
- Conditions
- Metastatic Cancer, Prostate Cancer
- Interventions
- atrasentan hydrochloride, docetaxel, prednisone, placebo
- Lead sponsor
- SWOG Cancer Research Network
- Results first posted
- 2017-05-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00134056?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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