Comparison · NCT01807065-sae
Arm A (Sipuleucel-T) vs Arm B (Radiation Therapy, Sipuleucel-T): 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 A (Sipuleucel-T) vs Arm B (Radiation Therapy, Sipuleucel-T): serious adverse events. Trial comparisons, record NCT01807065-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01807065-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 | 0.04 | 0.0071 | 0.195 | wilson | |
| Risk in group 2 | 0.0417 | 0.00739 | 0.202 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00167 | -0.166 | 0.158 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.96 | 0.0636 | 14.5 | log | |
| Odds ratio, group 1 over group 2 | 0.958 | 0.0565 | 16.2 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm A (Sipuleucel-T) than on Arm B (Radiation Therapy, Sipuleucel-T) | 600 | 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 (Sipuleucel-T) | Patients receive sipuleucel-T IV over 60 minutes days 22, 36, and 50. Each dose of sipuleucel-T contains a minimum of 50 million activated CD54+ cells.~sipuleucel-T: Given IV~laboratory biomarker analysis: Correlative studies | 1 | 25 | EG000 |
| Group 2 | Arm B (Radiation Therapy, Sipuleucel-T) | Patients undergo external beam radiation therapy in weeks 1-2. Radiation given in 10 fractions of 300cGy for a total dose of 3000cGy. Patients also receive sipuleucel-T as in Arm A.~sipuleucel-T: Given IV~external beam radiation therapy: Undergo external beam radiation therapy~laboratory biomarker analysis: Correlative studies | 1 | 24 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected over a period of 1 year and 3 months.
Source ClinicalTrials.gov
Trial
- Title
- Sipuleucel-T With or Without Radiation Therapy in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer
- NCT number
- NCT01807065
- Phases
- PHASE2
- Conditions
- Adenocarcinoma of the Prostate, Bone Metastases, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer, Soft Tissue Metastases, Stage IV Prostate Cancer
- Interventions
- sipuleucel-T, external beam radiation therapy, laboratory biomarker analysis
- Lead sponsor
- City of Hope Medical Center
- Results first posted
- 2020-08-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01807065?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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