Comparison · NCT00779402-sae
Sipuleucel-T vs Control: 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 vs Control: serious adverse events. Trial comparisons, record NCT00779402-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00779402-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 | 0.267 | 0.195 | 0.354 | wilson | |
| Risk in group 2 | 0.322 | 0.217 | 0.449 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0548 | -0.201 | 0.0817 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.83 | 0.515 | 1.34 | log | |
| Odds ratio, group 1 over group 2 | 0.768 | 0.388 | 1.52 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Sipuleucel-T than on Control | 18.3 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Sipuleucel-T | Provenge~Provenge: Biologic: autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of PAP, linked to GM-CSF | 31 | 116 | EG000 |
| Group 2 | Control | Control~Control: Autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen | 19 | 59 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
AEs, regardless of relationship to product, were collected from the time of randomization through 6 months following booster administration. If the subject didn't receive a booster infusion, all AEs were collected until the time of confirmation that a booster infusion will not occur. After that time, only product related events, or any cerebrovascular event, were collected throughout the remainder of the subject's study participation (surveillance and long term follow-up study phases).
Source ClinicalTrials.gov
Trial
- Title
- PROvenge Treatment and Early Cancer Treatment
- NCT number
- NCT00779402
- Phases
- PHASE3
- Conditions
- Prostate Cancer
- Interventions
- Control, Sipuleucel-T
- Lead sponsor
- Dendreon
- Results first posted
- 2018-01-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00779402?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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