Comparison · NCT03570697-sae
Evolocumab 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. Evolocumab vs Placebo: serious adverse events. Trial comparisons, record NCT03570697-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03570697-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 | 0.163 | 0.0975 | 0.258 | wilson | |
| Risk in group 2 | 0.198 | 0.125 | 0.297 | wilson | |
| Risk difference, group 1 minus group 2 | -0.035 | -0.154 | 0.085 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.823 | 0.424 | 1.6 | log | |
| Odds ratio, group 1 over group 2 | 0.788 | 0.352 | 1.77 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Evolocumab than on Placebo | 28.5 | 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 | Evolocumab | Evolocumab 420 mg SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation. | 13 | 80 | EG001 |
| Group 2 | Placebo | Placebo SC injection QM for 48 weeks. Background maximally tolerated statin therapy for the duration of the study participation. | 16 | 81 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All cause mortality reporting period is from the 1st dose of investigational product (IP) up to the end of study (EOS) date (Week 52). Adverse event (AE) reporting period is from the 1st dose of IP up to and including 30 days after the last dose of IP date or the EOS date (Week 52) whichever is earlier.
Source ClinicalTrials.gov
Trial
- Title
- Imaging of Coronary Plaques in Participants Treated With Evolocumab
- NCT number
- NCT03570697
- Phases
- PHASE3
- Conditions
- Coronary Artery Disease (CAD)
- Interventions
- Evolocumab, Placebo, Statin therapy
- Lead sponsor
- Amgen
- Results first posted
- 2021-11-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03570697?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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