Comparison · NCT03040999-sae
Pembrolizumab + CRT + Pembrolizumab vs Placebo + CRT + 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 + CRT + Pembrolizumab vs Placebo + CRT + Placebo: serious adverse events. Trial comparisons, record NCT03040999-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03040999-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 | 0.616 | 0.567 | 0.662 | wilson | |
| Risk in group 2 | 0.495 | 0.446 | 0.544 | wilson | |
| Risk difference, group 1 minus group 2 | 0.121 | 0.0516 | 0.188 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.24 | 1.1 | 1.41 | log | |
| Odds ratio, group 1 over group 2 | 1.63 | 1.23 | 2.17 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Pembrolizumab + CRT + Pembrolizumab than on Placebo + CRT + Placebo | 8.29 | 5.32 | 19.4 | from the risk difference interval |
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 + CRT + Pembrolizumab | On Cycle 1 Day 1 (each cycle is 21 days), participants received a priming dose of 200 mg Pembrolizumab followed by 100 mg/m\^2 Cisplatin PLUS 70 Gray (Gy) Radiotherapy (accelerated (AFX) or standard fractionation radiotherapy (SFX)) on Day 8 of Cycles 1, 2 and Cycle 3 (SFX RT regimen only). During CRT, participants received 2 doses of pembrolizumab (Day 1 of Cycles 2 and 3) and up to 3 cycles of Cisplatin (2 cycles during AFX and 3 cycles during SFX RT). Participants also received up to an additional 14 cycles of pembrolizumab alone as maintenance therapy for a total of 17 cycles of pembrolizumab (approximately 1 year). If cisplatin and/or radiation therapy was discontinued, the participant may continue on treatment with pembrolizumab. | 245 | 398 | EG000 |
| Group 2 | Placebo + CRT + Placebo | On Cycle 1 Day 1 (each cycle is 21 days), participants received placebo followed by 100 mg/m\^2 Cisplatin PLUS 70 Gray (Gy) Radiotherapy (accelerated (AFX) or standard fractionation radiotherapy (SFX)) on Day 8 of Cycles 1, 2 and Cycle 3 (SFX RT regimen only). During CRT, participants received 2 doses of placebo (Day 1 of Cycles 2 and 3) and up to 3 cycles of Cisplatin (2 cycles during AFX and 3 cycles during SFX RT). Participants also received up to an additional 14 cycles of placebo alone as maintenance therapy for a total of 17 cycles of placebo (approximately 1 year). If cisplatin and/or radiation therapy was discontinued, the participant may continue on treatment with placebo. | 197 | 398 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to approximately 88 months
Source ClinicalTrials.gov
Trial
- Title
- Study of Pembrolizumab (MK-3475) or Placebo With Chemoradiation in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-412/KEYNOTE-412)
- NCT number
- NCT03040999
- Phases
- PHASE3
- Conditions
- Head and Neck Neoplasms
- Interventions
- Pembrolizumab, Placebo, Cisplatin, Accelerated Fractionation (AFX) Radiotherapy, Standard Fractionation (SFX) Radiotherapy
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2023-06-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03040999?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
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GET https://conductscience.org/api/comparisons/v1/NCT03040999-sae