Comparison · NCT03510715-sae
Alirocumab 75 mg Q2W/up to 150 mg Q2W vs Alirocumab 150 mg Q2W: 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. Alirocumab 75 mg Q2W/up to 150 mg Q2W vs Alirocumab 150 mg Q2W: serious adverse events. Trial comparisons, record NCT03510715-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03510715-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 | 0.111 | 0.0199 | 0.435 | wilson | |
| Risk in group 2 | 0 | 0 | 0.299 | wilson | |
| Risk difference, group 1 minus group 2 | 0.111 | -0.202 | 0.435 | 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 Alirocumab 75 mg Q2W/up to 150 mg Q2W than on Alirocumab 150 mg Q2W | 9 | 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 | Alirocumab 75 mg Q2W/up to 150 mg Q2W | Participants with BW \<50 kg received SC injection of alirocumab 75 mg Q2W for 48 weeks. Alirocumab dose was up-titrated to 150 mg Q2W from Week 12 in case of increase in BW with BW \>=50 kg. | 1 | 9 | EG000 |
| Group 2 | Alirocumab 150 mg Q2W | Participants with BW \>=50 kg received SC injection of alirocumab 150 mg Q2W for 48 weeks. | 0 | 9 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All Adverse Events (AEs) were collected from signature of the informed consent form up to 56 weeks of the study regardless of seriousness or relationship to investigational product.
Source ClinicalTrials.gov
Trial
- Title
- An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia
- NCT number
- NCT03510715
- Phases
- PHASE3
- Conditions
- Hypercholesterolemia
- Interventions
- Alirocumab SAR236553 (REGN727), Atorvastatin, Simvastatin, Fluvastatin, Pravastatin, Lovastatin, Rosuvastatin, Ezetimibe, Cholestyramine, Nicotinic acid, Fenofibrate, Omega-3 fatty acids
- Lead sponsor
- Sanofi
- Results first posted
- 2020-12-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03510715?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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