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Comparison · NCT02536378-deaths

PP (Per Protocol) vs ITT (Intention to Treat): 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. PP (Per Protocol) vs ITT (Intention to Treat): deaths from any cause. Trial comparisons, record NCT02536378-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02536378-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 10.001580.0002790.00891wilson
Risk in group 20.004340.001480.0127wilson
Risk difference, group 1 minus group 2-0.00275-0.01120.00511newcombe hybrid score
Risk ratio, group 1 over group 20.3650.03813.5log
Odds ratio, group 1 over group 20.3640.03783.51log
Number needed to treat, for one fewer death from any cause on PP (Per Protocol) than on ITT (Intention to Treat)363from 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 1PP (Per Protocol)
Patients who underwent the study procedure, independent of the success of the procedure and in the absence of major protocol deviations. The analysis of the PP population excludes those subjects for whom a major protocol deviation was identified by the CEC
1632EG000
Group 2ITT (Intention to Treat)All patients who were enrolled in the pivotal phase of the study in which a major protocol deviation was identified by the CEC.3692EG001

Harm

What it counts
Total, all-cause mortality
Time frame
Adverse events were collected throughout the life of the study: 3 years, 6 months

Source ClinicalTrials.gov

Trial

Title
POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE
NCT number
NCT02536378
Phases
Conditions
Carotid Artery Disease
Interventions
Lead sponsor
Silk Road Medical
Results first posted
2020-07-29

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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