Comparison · NCT05323656-sae
Setanaxib 1600 mg and Pembrolizumab 200 mg vs Placebo and Pembrolizumab 200 mg: 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. Setanaxib 1600 mg and Pembrolizumab 200 mg vs Placebo and Pembrolizumab 200 mg: serious adverse events. Trial comparisons, record NCT05323656-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05323656-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 | 0.296 | 0.159 | 0.485 | wilson | |
| Risk in group 2 | 0.357 | 0.207 | 0.542 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0608 | -0.291 | 0.18 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.83 | 0.386 | 1.78 | log | |
| Odds ratio, group 1 over group 2 | 0.758 | 0.244 | 2.35 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Setanaxib 1600 mg and Pembrolizumab 200 mg than on Placebo and Pembrolizumab 200 mg | 16.4 | 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 | Setanaxib 1600 mg and Pembrolizumab 200 mg | Participants will be administered setanaxib at a dose of 1600 mg/day for the up to 24-month double-blind treatment period.~Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.~Setanaxib: Oral tablets, 400 mg per tablet~Pembrolizumab: 200 mg IV infusion | 8 | 27 | EG000 |
| Group 2 | Placebo and Pembrolizumab 200 mg | Participants will be administered placebo for the up to 24-month double-blind treatment period.~Participants will also be administered Pembrolizumab 200 mg intravenously every 3 weeks.~Placebo: Oral tablets~Pembrolizumab: 200 mg IV infusion | 10 | 28 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Reporting of AEs began when the patient had provided informed consent and continued up to 28 days after the last IMP administration, up to 27 months.
Source ClinicalTrials.gov
Trial
- Title
- A Study of Setanaxib Co-Administered With Pembrolizumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)
- NCT number
- NCT05323656
- Phases
- PHASE2
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Interventions
- Setanaxib, Pembrolizumab, Placebo
- Lead sponsor
- Calliditas Therapeutics Suisse SA
- Results first posted
- 2025-05-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05323656?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.govNone 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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