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Comparison · NCT05323656-deaths

Setanaxib 1600 mg and Pembrolizumab 200 mg vs Placebo and Pembrolizumab 200 mg: deaths from any cause

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. Setanaxib 1600 mg and Pembrolizumab 200 mg vs Placebo and Pembrolizumab 200 mg: deaths from any cause. Trial comparisons, record NCT05323656-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05323656-deaths

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.2220.1060.408wilson
Risk in group 20.4640.2950.642wilson
Risk difference, group 1 minus group 2-0.242-0.4540.00874newcombe hybrid score
Risk ratio, group 1 over group 20.4790.2131.08log
Odds ratio, group 1 over group 20.330.1021.06log
Number needed to treat, for one fewer death from any cause on Setanaxib 1600 mg and Pembrolizumab 200 mg than on Placebo and Pembrolizumab 200 mg4.13from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Setanaxib 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
627EG000
Group 2Placebo 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
1328EG001

Harm

What it counts
Total, all-cause mortality
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

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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