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Comparison · NCT03365791-deaths

PDR001+LAG525 On-treatment Period vs PDR001+LAG525 Extended Safety Follow-up Period: 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. PDR001+LAG525 On-treatment Period vs PDR001+LAG525 Extended Safety Follow-up Period: deaths from any cause. Trial comparisons, record NCT03365791-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03365791-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 10.1180.06360.21wilson
Risk in group 20.2370.1550.344wilson
Risk difference, group 1 minus group 2-0.118-0.2380.00413newcombe hybrid score
Risk ratio, group 1 over group 20.50.241.04log
Odds ratio, group 1 over group 20.4330.1811.04log
Number needed to treat, for one fewer death from any cause on PDR001+LAG525 On-treatment Period than on PDR001+LAG525 Extended Safety Follow-up Period8.44from 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 1PDR001+LAG525 On-treatment PeriodPDR001 300 mg and LAG525 400 mg administered via i.v. infusion over 30 minutes once every 3 weeks (Q3W). LAG525 was given first followed by PDR001976EG000
Group 2PDR001+LAG525 Extended Safety Follow-up PeriodPDR001 300 mg and LAG525 400 mg administered via i.v. infusion over 30 minutes once every 3 weeks (Q3W). LAG525 was given first followed by PDR0011876EG001

Harm

What it counts
Total, all-cause mortality
Time frame
In the on-treatment period, adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment. In the extended safety follow-up period, AEs and serious AEs (including the All-Cause Mortality data table) are presented from day 31 to day 150 after last administration of study treatment.

Source ClinicalTrials.gov

Trial

Title
PDR001 Plus LAG525 for Patients With Advanced Solid and Hematologic Malignancies
NCT number
NCT03365791
Phases
PHASE2
Conditions
Small Cell Lung Cancer, Gastric Adenocarcinoma, Esophageal Adenocarcinoma, Castration Resistant Prostate Adenocarcinoma, Soft Tissue Sarcoma, Ovarian Adenocarcinoma, Advanced Well-differentiated Neuroendocrine Tumors, Diffuse Large B Cell Lymphoma
Interventions
PDR001, LAG525
Lead sponsor
Novartis Pharmaceuticals
Results first posted
2021-04-19

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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