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Comparison · NCT03189719-deaths

Pembrolizumab + SOC vs Placebo + SOC: 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. Pembrolizumab + SOC vs Placebo + SOC: deaths from any cause. Trial comparisons, record NCT03189719-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03189719-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 10.8870.8510.916wilson
Risk in group 20.9650.9420.98wilson
Risk difference, group 1 minus group 2-0.078-0.117-0.0412newcombe hybrid score
Risk ratio, group 1 over group 20.9190.8820.958log
Odds ratio, group 1 over group 20.2820.1490.535log
Number needed to treat, for one fewer death from any cause on Pembrolizumab + SOC than on Placebo + SOC12.88.5624.3from the risk difference interval

Groups2

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

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Pembrolizumab + SOC
Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
331373EG000
Group 2Placebo + SOC
Participants received placebo to pembrolizumab (saline) IV Q3W along with SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.
363376EG001

Harm

What it counts
Total, all-cause mortality
Time frame
Up to approximately 70 months

Source ClinicalTrials.gov

Trial

Title
First-line Esophageal Carcinoma Study With Pembrolizumab Plus Chemo vs. Chemo (MK-3475-590/KEYNOTE-590)
NCT number
NCT03189719
Phases
PHASE3
Conditions
Esophageal Neoplasms
Interventions
Pembrolizumab, Placebo, Cisplatin, 5-FU
Lead sponsor
Merck Sharp & Dohme LLC
Results first posted
2021-07-06

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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