Comparison · NCT00134056-cf67cd32
Arm II: Atrasentan vs Arm I: Placebo: Compare Elements of Quality of Life Between Treatment Arms: Pain Palliation Response, as Measured by the Brief Pain Inventory (BPI)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
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ConductScience Library. Arm II: Atrasentan vs Arm I: Placebo: Compare Elements of Quality of Life Between Treatment Arms: Pain Palliation Response, as Measured by the Brief Pain Inventory (BPI). Trial comparisons, record NCT00134056-cf67cd32. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00134056-cf67cd32
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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 | 0.319 | 0.266 | 0.378 | wilson | |
| Risk in group 2 | 0.274 | 0.224 | 0.329 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0455 | -0.0318 | 0.122 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.17 | 0.897 | 1.52 | log | |
| Odds ratio, group 1 over group 2 | 1.24 | 0.858 | 1.81 | log | |
| Number needed to treat, for one more participant with the outcome on Arm II: Atrasentan than on Arm I: Placebo | 22 | 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.~atrasentan hydrochloride: Given orally~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally | 83 | 260 | OG001 |
| 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.~docetaxel: Docetaxel given IV and prednisone given orally~prednisone: Docetaxel given IV and prednisone given orally~placebo: Given orally | 75 | 274 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- OTHER_PRE_SPECIFIED
- Title
- Compare Elements of Quality of Life Between Treatment Arms: Pain Palliation Response, as Measured by the Brief Pain Inventory (BPI)
- Description
Pain palliation is the proportion of patients showing a two-point reduction in the Worst Pain score (WPS) maintained for two consecutive assessments with no increase in analgesic use. Increase in analgesic use is defined as an increase in Analgesic code Level to 2 (weak opioid) or 3 (strong opioid). Patients will be classified as pain palliated or not palliated. Patients with a WPS of 0 will be defined as stable if their WPS remains 0 for Weeks 7 and 10 with no increase in analgesic use, but they will not be categorized as responders. Pain palliation response is measured by BPI short form that has the following: yes/no question about pain today; 4 pain rating questions (worst pain, least pain, average pain, and current pain); pain medications and pain relief; 7 items addressing effect of pain on functioning. For patients who continue to receive treatment beyond 12 treatment cycles, the Worst Pain item is measured by Pain Medication Log and Pain Assessment
- Time frame
- up to 18 months study period
- Population
There was a large amount of missing data points due to the difficulty of data collection of pain medication logs in addition to a questionnaire.The study team and site staff were only able to obtain complete data for the patients included in this analysis.
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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