Comparison · NCT01560923-sae
Sipuleucel-T + Indoximod vs Sipuleucel-T + 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 + Indoximod vs Sipuleucel-T + Placebo: serious adverse events. Trial comparisons, record NCT01560923-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01560923-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 | 0.0909 | 0.0253 | 0.278 | wilson | |
| Risk in group 2 | 0.0417 | 0.00739 | 0.202 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0492 | -0.124 | 0.24 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.18 | 0.212 | 22.4 | log | |
| Odds ratio, group 1 over group 2 | 2.3 | 0.194 | 27.3 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Sipuleucel-T + Indoximod than on Sipuleucel-T + Placebo | 20.3 | 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 + Indoximod | Oral Indoximod will be self-administered by mouth twice daily (1200 mg) for 6 months starting after the last (3rd) infusion of sipuleucel-T. Indoximod is a sterile tan powder compounded in capsule form of 200 mg.~Indoximod: Given twice daily (1200 mg total) by mouth for 6 months.~Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday). | 2 | 22 | EG000 |
| Group 2 | Sipuleucel-T + Placebo | Placebo is identical-looking to Indoximod and provided in the same manner.~Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).~Placebo: Given in same manner as Indoximod; 1200 mg per day by mouth. | 1 | 24 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 28 days
Source ClinicalTrials.gov
Trial
- Title
- Phase II Study of Sipuleucel-T and Indoximod for Patients With Refractory Metastatic Prostate Cancer
- NCT number
- NCT01560923
- Phases
- PHASE2
- Conditions
- Metastatic Prostate Cancer
- Interventions
- Indoximod, Sipuleucel-T, Placebo
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Results first posted
- 2020-04-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01560923?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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