Comparison · NCT00065442-sae
Sipuleucel-T vs APC-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
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ConductScience Library. Sipuleucel-T vs APC-Placebo: serious adverse events. Trial comparisons, record NCT00065442-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00065442-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 | 0.243 | 0.2 | 0.291 | wilson | |
| Risk in group 2 | 0.238 | 0.18 | 0.308 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00451 | -0.0773 | 0.0801 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.02 | 0.733 | 1.42 | log | |
| Odds ratio, group 1 over group 2 | 1.03 | 0.664 | 1.58 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Sipuleucel-T than on APC-Placebo | 222 | 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 | Sipuleucel-T | All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart. | 82 | 338 | EG001 |
| Group 2 | APC-Placebo | All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals. | 40 | 168 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From randomization until time of overall survival analysis.
Source ClinicalTrials.gov
Trial
- Title
- Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
- NCT number
- NCT00065442
- Phases
- PHASE3
- Conditions
- Prostate Cancer
- Interventions
- Sipuleucel-T, APC-Placebo
- Lead sponsor
- Dendreon
- Results first posted
- 2010-09-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00065442?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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