Comparison · NCT03834493-af24643c
Pembrolizumab + Enzalutamide vs Placebo + Enzalutamide: Number of Participants Who Experience an Adverse Event (AE)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Pembrolizumab + Enzalutamide vs Placebo + Enzalutamide: Number of Participants Who Experience an Adverse Event (AE). Trial comparisons, record NCT03834493-af24643c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03834493-af24643c
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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 | 0.966 | 0.948 | 0.978 | wilson | |
| Risk in group 2 | 0.961 | 0.943 | 0.974 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00456 | -0.017 | 0.0262 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.983 | 1.03 | log | |
| Odds ratio, group 1 over group 2 | 1.14 | 0.627 | 2.07 | log | |
| Number needed to treat, for one more participant with the outcome on Pembrolizumab + Enzalutamide than on Placebo + Enzalutamide | 219 | 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 | Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) PLUS enzalutamide 160 mg administered orally (PO) once a day (QD) continuously until progression. | 594 | 615 | OG000 |
| Group 2 | Placebo + Enzalutamide | Participants received placebo by IV infusion administered on Day 1 Q3W for up to 35 cycles (approximately 2 years) PLUS enzalutamide 160 mg administered PO QD continuously until progression. | 596 | 620 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Who Experience an Adverse Event (AE)
- Description
An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality. The number of participants who experienced an AE is presented.
- Time frame
- Up to 40 months (through database cut-off date of 12-Dec-2022)
- Population
- All randomized participants who received at least 1 dose of study treatment.
Source ClinicalTrials.gov
Trial
- Title
- Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641)
- NCT number
- NCT03834493
- Phases
- PHASE3
- Conditions
- Prostatic Neoplasms
- Interventions
- Pembrolizumab, Enzalutamide, Placebo
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2023-12-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03834493?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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