Comparison · NCT02392559-sae
EvoMab 420 mg SC QM vs Placebo SC QM: 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. EvoMab 420 mg SC QM vs Placebo SC QM: serious adverse events. Trial comparisons, record NCT02392559-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02392559-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 | 0.00962 | 0.0017 | 0.0525 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0676 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00962 | -0.0584 | 0.0525 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm, for one more participant with a serious adverse event on EvoMab 420 mg SC QM than on Placebo SC QM | 104 | 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 | EvoMab 420 mg SC QM | Evolocumab subcutaneous injection QM | 1 | 104 | EG001 |
| Group 2 | Placebo SC QM | Matching subcutaneous injection QM | 0 | 53 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
Source ClinicalTrials.gov
Trial
- Title
- Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders
- NCT number
- NCT02392559
- Phases
- PHASE3
- Conditions
- Heterozygous Familial Hypercholesterolemia
- Interventions
- Evolocumab, Placebo
- Lead sponsor
- Amgen
- Results first posted
- 2020-07-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02392559?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.
For software
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