Comparison · NCT02777385-sae
Cisplatin + Radiation + Pembrolizumab - Concurrent vs Cisplatin + Radiation + Pembrolizumab - Sequential: 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. Cisplatin + Radiation + Pembrolizumab - Concurrent vs Cisplatin + Radiation + Pembrolizumab - Sequential: serious adverse events. Trial comparisons, record NCT02777385-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02777385-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 | 0.512 | 0.365 | 0.657 | wilson | |
| Risk in group 2 | 0.256 | 0.146 | 0.411 | wilson | |
| Risk difference, group 1 minus group 2 | 0.256 | 0.0424 | 0.438 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2 | 1.08 | 3.68 | log | |
| Odds ratio, group 1 over group 2 | 3.05 | 1.18 | 7.83 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Cisplatin + Radiation + Pembrolizumab - Concurrent than on Cisplatin + Radiation + Pembrolizumab - Sequential | 3.91 | 2.28 | 23.6 | 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 | Cisplatin + Radiation + Pembrolizumab - Concurrent | Cisplatin and Radiation and Pembrolizumab given 1 week prior to the start of cisplatin and radiation and given every 3 weeks~Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.~Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.~IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan. | 21 | 41 | EG000 |
| Group 2 | Cisplatin + Radiation + Pembrolizumab - Sequential | Cisplatin, Radiation, and Pembrolizumab started 3 weeks after completion of cisplatin and radiation.~Pembrolizumab: In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.~Cisplatin: Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.~IMRT: IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan. | 10 | 39 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 48 months
Source ClinicalTrials.gov
Trial
- Title
- Pembrolizumab in Combination With Cisplatin and Intensity Modulated Radiotherapy (IMRT) in Head and Neck Cancer
- NCT number
- NCT02777385
- Phases
- PHASE2
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Interventions
- Pembrolizumab, Cisplatin, IMRT
- Lead sponsor
- Dan Zandberg
- Results first posted
- 2024-08-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02777385?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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