Evolocumab vs Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.248 | 0.241 | 0.255 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.247 | 0.24 | 0.255 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.000202 | -0.00999 | 0.0104 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1 | 0.96 | 1.04 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1 | 0.948 | 1.06 | log | ClinicalTrials.gov | |
| Number needed to harm, for one more participant with a serious adverse event on Evolocumab than on Placebo | 4,950 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Evolocumab | Participants received evolocumab subcutaneous injections either 140 mg Q2W or 420 mg QM according to their own preference. | 3,410 | 13,769 | EG001 | ClinicalTrials.gov |
| Group 2 | Placebo | Participants received placebo subcutaneous injections either once every 2 weeks (Q2W) or once a month (QM) according to their own preference. | 3,404 | 13,756 | EG000 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | From the first dose of study drug to the end of study. The median duration of follow-up was 26 months. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk | ClinicalTrials.gov |
| NCT number | NCT01764633 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Dyslipidemia | ClinicalTrials.gov |
| Interventions | Evolocumab, Placebo | ClinicalTrials.gov |
| Lead sponsor | Amgen | ClinicalTrials.gov |
| Results first posted | 2018-02-15 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT01764633?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.