Comparison · NCT01984424-sae
Evolocumab vs Ezetimibe: 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 Ezetimibe: serious adverse events. Trial comparisons, record NCT01984424-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01984424-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 | 0.0621 | 0.033 | 0.114 | wilson | |
| Risk in group 2 | 0.137 | 0.0761 | 0.234 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0749 | -0.176 | 0.00491 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.453 | 0.193 | 1.07 | log | |
| Odds ratio, group 1 over group 2 | 0.417 | 0.161 | 1.08 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Evolocumab than on Ezetimibe | 13.3 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Evolocumab | Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks. | 9 | 145 | EG000 |
| Group 2 | Ezetimibe | Participants received 10 mg ezetimibe orally only a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks. | 10 | 73 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 6 months
Source ClinicalTrials.gov
Trial
- Title
- Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3
- NCT number
- NCT01984424
- Phases
- PHASE3
- Conditions
- Hyperlipidemia
- Interventions
- Atorvastatin, Placebo to Atorvastatin, Placebo to Ezetimibe, Ezetimibe, Placebo to Evolocumab, Evolocumab
- Lead sponsor
- Amgen
- Results first posted
- 2018-03-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01984424?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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