Comparison · NCT03686683-sae
Treatment Group: Sipuleucel-T vs Control Arm: Active Surveillance: 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. Treatment Group: Sipuleucel-T vs Control Arm: Active Surveillance: serious adverse events. Trial comparisons, record NCT03686683-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03686683-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 | 0.214 | 0.174 | 0.261 | wilson | |
| Risk in group 2 | 0.125 | 0.084 | 0.182 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0895 | 0.0198 | 0.151 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.72 | 1.11 | 2.66 | log | |
| Odds ratio, group 1 over group 2 | 1.91 | 1.14 | 3.2 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Treatment Group: Sipuleucel-T than on Control Arm: Active Surveillance | 11.2 | 6.61 | 50.4 | from the risk difference interval |
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 | Treatment Group: Sipuleucel-T | Sipuleucel-T is an autologous cellular immunotherapy available as a suspension for intravenous infusion. Subjects randomized to sipuleucel-T arm will receive 3 infusions of sipuleucel-T at approximately 2-week intervals.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF). | 74 | 345 | EG000 |
| Group 2 | Control Arm: Active Surveillance | Subjects randomized to the control arm will be followed on Active Surveillance described in the schedule of events. | 22 | 176 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 4 years, 5 months
Source ClinicalTrials.gov
Trial
- Title
- Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer
- NCT number
- NCT03686683
- Phases
- PHASE3
- Conditions
- Adenocarcinoma of the Prostate
- Interventions
- sipuleucel-T
- Lead sponsor
- Dendreon
- Results first posted
- 2024-10-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03686683?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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