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Comparison · NCT03399370-deaths

Inclisiran vs Saline Solution: 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. Inclisiran vs Saline Solution: deaths from any cause. Trial comparisons, record NCT03399370-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03399370-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 10.01540.008810.0267wilson
Risk in group 20.01410.007910.0251wilson
Risk difference, group 1 minus group 20.00123-0.01160.0141newcombe hybrid score
Risk ratio, group 1 over group 21.090.4822.45log
Odds ratio, group 1 over group 21.090.4772.48log
Number needed to harm, for one more death from any cause on Inclisiran than on Saline Solution816from 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 1Inclisiran
Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.~Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
12781EG000
Group 2Saline Solution
Placebo will be administered as a SC injection of saline solution on Day 1, Day 90, then every 6 months.~Placebo: Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).
11778EG001

Harm

What it counts
Total, all-cause mortality
Time frame
18 months

Source ClinicalTrials.gov

Trial

Title
Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol
NCT number
NCT03399370
Phases
PHASE3
Conditions
ASCVD, Elevated Cholesterol
Interventions
Inclisiran Sodium, Placebo
Lead sponsor
The Medicines Company
Results first posted
2020-10-05

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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