Comparison · NCT03397121-sae
Inclisiran vs Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Inclisiran vs Placebo: serious adverse events. Trial comparisons, record NCT03397121-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03397121-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0747 | 0.0478 | 0.115 | wilson | |
| Risk in group 2 | 0.138 | 0.0996 | 0.187 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0628 | -0.119 | -0.00752 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.543 | 0.315 | 0.938 | log | |
| Odds ratio, group 1 over group 2 | 0.506 | 0.277 | 0.927 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Inclisiran than on Placebo | 15.9 | 8.4 | 133 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Inclisiran | Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90 then every 6 months.~Inclisiran: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis. | 18 | 241 | EG000 |
| Group 2 | Placebo | Placebo will be administered as SC injections 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). | 33 | 240 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Day 0 - 510
Source ClinicalTrials.gov
Trial
- Title
- Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH)
- NCT number
- NCT03397121
- Phases
- PHASE3
- Conditions
- Heterozygous Familial Hypercholesterolemia, Elevated Cholesterol
- Interventions
- Inclisiran, Placebo
- Lead sponsor
- The Medicines Company
- Results first posted
- 2020-10-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03397121?tab=results
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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