Comparison · NCT04233918-426faee2
Part A: Evinacumab 15mg/Kg IV vs Part B: Evinacumab 15mg/Kg IV Q4W: Part A and Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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. Part A: Evinacumab 15mg/Kg IV vs Part B: Evinacumab 15mg/Kg IV Q4W: Part A and Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs). Trial comparisons, record NCT04233918-426faee2. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04233918-426faee2
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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 | 0.833 | 0.436 | 0.97 | wilson | |
| Risk in group 2 | 0.714 | 0.454 | 0.883 | wilson | |
| Risk difference, group 1 minus group 2 | 0.119 | -0.312 | 0.413 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.17 | 0.716 | 1.9 | log | |
| Odds ratio, group 1 over group 2 | 2 | 0.174 | 22.9 | log | |
| Number needed to treat, for one more participant with the outcome on Part A: Evinacumab 15mg/Kg IV than on Part B: Evinacumab 15mg/Kg IV Q4W | 8.4 | 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 | Part A: Evinacumab 15mg/Kg IV | Participants received single intravenous (IV) infusion of evinacumab at a dose of 15 milligrams per kilogram (mg/kg) on Day 1 in Part A. | 5 | 6 | OG000 |
| Group 2 | Part B: Evinacumab 15mg/Kg IV Q4W | Participants received IV infusion of evinacumab at a dose of 15 mg/kg every four weeks (Q4W) from Day 1 up to Week 24 in Part B. | 10 | 14 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Part A and Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
- Description
Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAE was defined as AE starting/worsening after first intake of study drug. TEAE included participants with both serious and non-serious AEs.~1 participant experienced an AE during part B that was recorded after Part B database lock. This was not reflected in the reported endpoint number of participants of 10.
- Time frame
- Part A: up to Week 24; Part B: up to Week 48
- Population
- The safety analysis set (SAF) includes all patients in Part A or Part B who received at least 1 dose or part of a dose of study drug in the respective study treatment period.
Source ClinicalTrials.gov
Trial
- Title
- Evaluate the Efficacy and Safety of Evinacumab in Pediatric Patients With Homozygous Familial Hypercholesterolemia
- NCT number
- NCT04233918
- Phases
- PHASE3
- Conditions
- Homozygous Familial Hypercholesterolemia
- Interventions
- Evinacumab
- Lead sponsor
- Regeneron Pharmaceuticals
- Results first posted
- 2023-06-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04233918?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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