Comparison · NCT01617655-sae
Alirocumab 150 Q2W vs Placebo 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 150 Q2W vs Placebo Q2W: serious adverse events. Trial comparisons, record NCT01617655-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01617655-sae
On this page
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 | 0.139 | 0.0772 | 0.237 | wilson | |
| Risk in group 2 | 0.114 | 0.0454 | 0.26 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0246 | -0.133 | 0.145 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.22 | 0.41 | 3.6 | log | |
| Odds ratio, group 1 over group 2 | 1.25 | 0.363 | 4.31 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Alirocumab 150 Q2W than on Placebo Q2W | 40.6 | 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 150 Q2W | Participants exposed to Alirocumab 150 mg Q2W on top of stable LMT (mean exposure of 68 weeks). | 10 | 72 | EG001 |
| Group 2 | Placebo Q2W | Participants exposed to placebo Q2W on top of stable LMT (mean exposure of 71 weeks). | 4 | 35 | EG000 |
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 the final visit in the study regardless of seriousness or relationship to study drug.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH)
- NCT number
- NCT01617655
- Phases
- PHASE3
- Conditions
- Hypercholesterolaemia
- Interventions
- Alirocumab, Placebo (for alirocumab), Lipid Modifying Therapy (LMT)
- Lead sponsor
- Sanofi
- Results first posted
- 2015-11-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01617655?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
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01617655-sae