Comparison · NCT04191096-deaths
Pembrolizumab + Enzalutamide + ADT vs Placebo + Enzalutamide + ADT: deaths from any cause
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. Pembrolizumab + Enzalutamide + ADT vs Placebo + Enzalutamide + ADT: deaths from any cause. Trial comparisons, record NCT04191096-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04191096-deaths
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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 | 0.168 | 0.141 | 0.199 | wilson | |
| Risk in group 2 | 0.149 | 0.123 | 0.179 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0189 | -0.0216 | 0.0594 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.13 | 0.873 | 1.46 | log | |
| Odds ratio, group 1 over group 2 | 1.15 | 0.851 | 1.56 | log | |
| Number needed to harm, for one more death from any cause on Pembrolizumab + Enzalutamide + ADT than on Placebo + Enzalutamide + ADT | 52.8 | 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 | Pembrolizumab + Enzalutamide + ADT | Participants received 200 mg pembrolizumab IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily (QD), while maintaining continuous ADT with a luteinizing-hormone releasing hormone (LHRH) agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation were met. | 105 | 626 | EG000 |
| Group 2 | Placebo + Enzalutamide + ADT | Participants received placebo IV on Day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally QD, while maintaining continuous ADT with a LHRH agonist or antagonist during study treatment. Participants received enzalutamide and ADT until criteria for discontinuation are met. | 93 | 625 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, all-cause mortality
- Time frame
- Up to Approximately 32 months
Source ClinicalTrials.gov
Trial
- Title
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991)
- NCT number
- NCT04191096
- Phases
- PHASE3
- Conditions
- Metastatic Hormone-Sensitive Prostate Cancer
- Interventions
- Pembrolizumab, Enzalutamide, Androgen Deprivation Therapy (ADT), Placebo
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2023-11-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04191096?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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