Comparison · NCT02463799-sae
Sipuleucel-T and Radium 223 Combination vs Sipuleucel-T Alone: 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 and Radium 223 Combination vs Sipuleucel-T Alone: serious adverse events. Trial comparisons, record NCT02463799-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02463799-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 | 0.125 | 0.035 | 0.36 | wilson | |
| Risk in group 2 | 0.0625 | 0.0111 | 0.283 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0625 | -0.176 | 0.303 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2 | 0.201 | 19.9 | log | |
| Odds ratio, group 1 over group 2 | 2.14 | 0.174 | 26.3 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Sipuleucel-T and Radium 223 Combination than on Sipuleucel-T Alone | 16 | 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 | Sipuleucel-T and Radium 223 Combination | Radium-223 will be administered by intravenous injection over 1 minute at 50kbq (1.35 microcurie) per kg body weight per standard of care every 4 weeks at weeks 0, 4, 8, 12, 16, and 20~Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10~Radium-223: 6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223~Sipuleucel-T: 3 infusions of sipuleucel-T alone | 2 | 16 | EG000 |
| Group 2 | Sipuleucel-T Alone | Sipuleucel-T will be administered intravenously per standard of care every 2 weeks at weeks 6, 8, and 10~Sipuleucel-T: 3 infusions of sipuleucel-T alone | 1 | 16 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 1 year
Source ClinicalTrials.gov
Trial
- Title
- Study of Sipuleucel-T W/ or W/O Radium-223 in Men With Asymptomatic or Minimally Symptomatic Bone-MCRPC
- NCT number
- NCT02463799
- Phases
- PHASE2
- Conditions
- Prostate Cancer
- Interventions
- Radium-223, Sipuleucel-T
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Results first posted
- 2021-07-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02463799?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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