Comparison · NCT00450619-3e6579db
Arm A - EDTMP Alone vs Arm B - 153Sm-EDTMP With Vaccine: Palliation: Improvement in Baseline Pain
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Arm A - EDTMP Alone vs Arm B - 153Sm-EDTMP With Vaccine: Palliation: Improvement in Baseline Pain. Trial comparisons, record NCT00450619-3e6579db. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00450619-3e6579db
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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 | 0.6 | 0.313 | 0.832 | wilson | |
| Risk in group 2 | 0.625 | 0.306 | 0.863 | wilson | |
| Risk difference, group 1 minus group 2 | -0.025 | -0.398 | 0.37 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.96 | 0.459 | 2.01 | log | |
| Odds ratio, group 1 over group 2 | 0.9 | 0.133 | 6.08 | log | |
| Number needed to treat, for one fewer participant with the outcome on Arm A - EDTMP Alone than on Arm B - 153Sm-EDTMP With Vaccine | 40 | 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 | Arm A - EDTMP Alone | Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity. | 6 | 10 | OG000 |
| Group 2 | Arm B - 153Sm-EDTMP With Vaccine | Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10\^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10\^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF\* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I. | 5 | 8 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Palliation: Improvement in Baseline Pain
- Description
Subjective report of participant pain at baseline. This data reflects National Cancer Institute (NCI) patients only. This data was not systematically captured, so these results are based on subjective patient reports of improvement in pain on a scale of 1-10 post quadramet (samarium) as documented in the progress notes. 1-2 equals mild pain and 9-10 equals worst possible pain.
- Time frame
- post quadramet (samarium)
- Population
Source ClinicalTrials.gov
Trial
- Title
- 153Sm-EDTMP With or Without a PSA/TRICOM Vaccine To Treat Men With Androgen-Insensitive Prostate Cancer
- NCT number
- NCT00450619
- Phases
- PHASE2
- Conditions
- Prostate Cancer
- Interventions
- Samarium Sm 153 lexidronam pentasodium, Sargramostim, Recombinant vaccinia-TRICOM vaccine, Recombinant fowlpox-TRICOM vaccine
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2013-07-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00450619?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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