Comparison · NCT03142334-sae
Pembrolizumab vs 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. Pembrolizumab vs Placebo: serious adverse events. Trial comparisons, record NCT03142334-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03142334-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 | 0.205 | 0.171 | 0.243 | wilson | |
| Risk in group 2 | 0.113 | 0.088 | 0.144 | wilson | |
| Risk difference, group 1 minus group 2 | 0.092 | 0.0465 | 0.138 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.81 | 1.34 | 2.46 | log | |
| Odds ratio, group 1 over group 2 | 2.03 | 1.42 | 2.89 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Pembrolizumab than on Placebo | 10.9 | 7.27 | 21.5 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Pembrolizumab | Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year). | 100 | 488 | EG000 |
| Group 2 | Placebo | Participants received placebo (saline solution) via IV infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year). | 56 | 496 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to approximately 43 months (Database cutoff date 14 Dec 2020).
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy Study of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (MK-3475-564/KEYNOTE-564)
- NCT number
- NCT03142334
- Phases
- PHASE3
- Conditions
- Renal Cell Carcinoma
- Interventions
- Pembrolizumab, Placebo
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2021-12-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03142334?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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