Comparison · NCT01133704-sae
Sipuleucel-T (APC8015) vs 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. Sipuleucel-T (APC8015) vs Placebo: serious adverse events. Trial comparisons, record NCT01133704-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01133704-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 | 0.2 | 0.121 | 0.313 | wilson | |
| Risk in group 2 | 0.29 | 0.161 | 0.466 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0903 | -0.283 | 0.0812 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.689 | 0.331 | 1.44 | log | |
| Odds ratio, group 1 over group 2 | 0.611 | 0.228 | 1.64 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Sipuleucel-T (APC8015) than on Placebo | 11.1 | 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 (APC8015) | 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 consist of 3 doses administered approximately 2 weeks apart. | 13 | 65 | EG000 |
| Group 2 | Placebo | All subjects randomized to receive placebo.~Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals. | 9 | 31 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From randomization through 36 months. Median follow-up was 36 months.
Source ClinicalTrials.gov
Trial
- Title
- Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer
- NCT number
- NCT01133704
- Phases
- PHASE3
- Conditions
- Hormone-Refractory Prostate Cancer
- Interventions
- sipuleucel-T, APC-Placebo
- Lead sponsor
- Dendreon
- Results first posted
- 2010-09-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01133704?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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