Comparison · NCT03400800-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
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ConductScience Library. Inclisiran vs Placebo: serious adverse events. Trial comparisons, record NCT03400800-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03400800-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 | 0.223 | 0.196 | 0.253 | wilson | |
| Risk in group 2 | 0.225 | 0.198 | 0.255 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00194 | -0.0426 | 0.0387 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.991 | 0.827 | 1.19 | log | |
| Odds ratio, group 1 over group 2 | 0.989 | 0.783 | 1.25 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Inclisiran than on Placebo | 515 | from the risk difference interval | the interval includes no difference |
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) (equivalent to 284 mg inclisiran) in 1.5 milliliters (mL) will be administered as a SC injection on Day 1, Day 90, and then every 6 months~Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis. | 181 | 811 | EG000 |
| Group 2 | Placebo | Placebo (1.5 mL) will be administered as a SC injection of saline solution on Day 1, Day 90, and then every 6 months~Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection). | 181 | 804 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 17 months
Source ClinicalTrials.gov
Trial
- Title
- Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol
- NCT number
- NCT03400800
- Phases
- PHASE3
- Conditions
- ASCVD, Risk Factor, Cardiovascular, Elevated Cholesterol
- Interventions
- Inclisiran Sodium, Placebo
- Lead sponsor
- The Medicines Company
- Results first posted
- 2020-08-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03400800?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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