Comparison · NCT03765918-sae
Pembrolizumab + Standard of Care (SOC) vs Standard of Care (SOC): 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 + Standard of Care (SOC) vs Standard of Care (SOC): serious adverse events. Trial comparisons, record NCT03765918-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03765918-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 | 0.496 | 0.445 | 0.547 | wilson | |
| Risk in group 2 | 0.368 | 0.317 | 0.423 | wilson | |
| Risk difference, group 1 minus group 2 | 0.128 | 0.0527 | 0.2 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.35 | 1.13 | 1.61 | log | |
| Odds ratio, group 1 over group 2 | 1.69 | 1.24 | 2.3 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Pembrolizumab + Standard of Care (SOC) than on Standard of Care (SOC) | 7.84 | 4.99 | 19 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard of care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). | 179 | 361 | EG000 |
| Group 2 | Standard of Care (SOC) | Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). | 116 | 315 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to ~66 months
Source ClinicalTrials.gov
Trial
- Title
- Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)
- NCT number
- NCT03765918
- Phases
- PHASE3
- Conditions
- Head and Neck Neoplasms
- Interventions
- Pembrolizumab 200 mg, Radiotherapy 60 Gray, Radiotherapy 66 Gray, Radiotherapy 70 Gray, Cisplatin 100 mg/m^2
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2025-08-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03765918?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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