Comparison · NCT01576484-sae
Participants Previously Exposed to Alirocumab in Parent Study vs Placebo Participants in Parent Study: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Participants Previously Exposed to Alirocumab in Parent Study vs Placebo Participants in Parent Study: serious adverse events. Trial comparisons, record NCT01576484-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01576484-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 | 0.174 | 0.0909 | 0.307 | wilson | |
| Risk in group 2 | 0.333 | 0.138 | 0.609 | wilson | |
| Risk difference, group 1 minus group 2 | -0.159 | -0.448 | 0.077 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.522 | 0.188 | 1.44 | log | |
| Odds ratio, group 1 over group 2 | 0.421 | 0.102 | 1.75 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Participants Previously Exposed to Alirocumab in Parent Study than on Placebo Participants in Parent Study | 6.27 | 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 | Participants Previously Exposed to Alirocumab in Parent Study | Participants who received alirocumab in parent study (NCT01266876), also received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | 8 | 46 | EG001 |
| Group 2 | Placebo Participants in Parent Study | Participants who received placebo in parent study (NCT01266876), received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study. | 4 | 12 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 218) regardless of seriousness or relationship to investigational product.
Source ClinicalTrials.gov
Trial
- Title
- Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)
- NCT number
- NCT01576484
- Phases
- PHASE2
- Conditions
- Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia
- Interventions
- Alirocumab, Placebo Matched to Alirocumab
- Lead sponsor
- Regeneron Pharmaceuticals
- Results first posted
- 2020-08-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01576484?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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