Comparison · NCT01709500-sae
Alirocumab 75 mg/up to 150 mg vs Placebo: 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/up to 150 mg vs Placebo: serious adverse events. Trial comparisons, record NCT01709500-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01709500-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 | 0.0599 | 0.0328 | 0.107 | wilson | |
| Risk in group 2 | 0.0864 | 0.0425 | 0.168 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0265 | -0.112 | 0.0377 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.693 | 0.274 | 1.75 | log | |
| Odds ratio, group 1 over group 2 | 0.673 | 0.247 | 1.84 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Alirocumab 75 mg/up to 150 mg than on Placebo | 37.7 | 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 | Alirocumab 75 mg/up to 150 mg | Alirocumab 75 mg SC injection every two weeks (Q2W) added to stable dose of statin with or without LMT for 76 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8. | 10 | 167 | EG000 |
| Group 2 | Placebo | Placebo matched to alirocumab SC injection for 78-week treatment duration. | 7 | 81 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From Baseline up to Week 78
Source ClinicalTrials.gov
Trial
- Title
- Study of Alirocumab (REGN727/SAR236553) in Patients With heFH (Heterozygous Familial Hypercholesterolemia) Who Are Not Adequately Controlled With Their LMT (Lipid-Modifying Therapy)
- NCT number
- NCT01709500
- Phases
- PHASE3
- Conditions
- Heterozygous Familial Hypercholesterolemia
- Interventions
- LMT (atorvastatin, simvastatin, or rosuvastatin), alirocumab, Placebo
- Lead sponsor
- Regeneron Pharmaceuticals
- Results first posted
- 2015-10-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01709500?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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