Comparison · NCT03040999-e343cc46
Pembrolizumab + CRT + Pembrolizumab vs Placebo + CRT + Placebo: Number of Participants Who Experienced 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 + CRT + Pembrolizumab vs Placebo + CRT + Placebo: Number of Participants Who Experienced an Adverse Event (AE). Trial comparisons, record NCT03040999-e343cc46. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03040999-e343cc46
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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 | 1 | 0.99 | 1 | wilson | |
| Risk in group 2 | 0.997 | 0.986 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00251 | -0.00727 | 0.0141 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.998 | 1.01 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on Pembrolizumab + CRT + Pembrolizumab than on Placebo + CRT + Placebo | 398 | 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 + 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. | 398 | 398 | OG000 |
| 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. | 397 | 398 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Who Experienced an Adverse Event (AE)
- Description
An AE was defined as any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with the study drug. An AE is any sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy. The number of participants who experienced an AE is presented.
- Time frame
- Up to approximately 88 months
- Population
- All randomized participants who received at least one dose of study treatment.
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.
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