Comparison · NCT01431391-sae
Arm 1: Sipuleucel-T Followed by ADT vs Arm 2: ADT Followed by 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 1: Sipuleucel-T Followed by ADT vs Arm 2: ADT Followed by Sipuleucel-T: serious adverse events. Trial comparisons, record NCT01431391-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01431391-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 | 0.0294 | 0.00521 | 0.149 | wilson | |
| Risk in group 2 | 0.147 | 0.0645 | 0.301 | wilson | |
| Risk difference, group 1 minus group 2 | -0.118 | -0.274 | 0.0278 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.2 | 0.0246 | 1.62 | log | |
| Odds ratio, group 1 over group 2 | 0.176 | 0.0194 | 1.59 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm 1: Sipuleucel-T Followed by ADT than on Arm 2: ADT Followed by Sipuleucel-T | 8.5 | 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 1: Sipuleucel-T Followed by ADT | Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. | 1 | 34 | EG000 |
| Group 2 | Arm 2: ADT Followed by Sipuleucel-T | Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions. | 5 | 34 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All non-serious adverse events (AE)s and serious adverse events (SAE)s, were collected at all visits through Month-6 or at early withdrawal.
Source ClinicalTrials.gov
Trial
- Title
- Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer
- NCT number
- NCT01431391
- Phases
- PHASE2
- Conditions
- Prostatic Neoplasm, Prostate Cancer, Prostatic Adenocarcinoma
- Interventions
- sipuleucel-T, leuprolide acetate
- Lead sponsor
- Dendreon
- Results first posted
- 2017-05-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01431391?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.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT01431391-sae