Comparison · NCT02362594-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 NCT02362594-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02362594-sae
On this page
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 | 0.251 | 0.216 | 0.291 | wilson | |
| Risk in group 2 | 0.163 | 0.134 | 0.198 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0881 | 0.0382 | 0.138 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.54 | 1.2 | 1.97 | log | |
| Odds ratio, group 1 over group 2 | 1.72 | 1.26 | 2.35 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Pembrolizumab than on Placebo | 11.3 | 7.27 | 26.2 | 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 | In Part 1, participants received pembrolizumab 200 mg IV as post-surgery therapy Q3W for up to 1 year. | 128 | 509 | EG000 |
| Group 2 | Placebo | In Part 1, participants received placebo IV as post-surgery therapy Q3W. | 82 | 502 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 29 months (through database cut-off date of 02-Oct-2017)
Source ClinicalTrials.gov
Trial
- Title
- Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/1325-MG/KEYNOTE-054)
- NCT number
- NCT02362594
- Phases
- PHASE3
- Conditions
- Melanoma
- Interventions
- pembrolizumab, placebo
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2019-01-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02362594?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT02362594-sae