Comparison · NCT01507831-sae
Alirocumab 150 mg 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 mg Q2W vs Placebo Q2W: serious adverse events. Trial comparisons, record NCT01507831-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01507831-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 | 0.187 | 0.168 | 0.207 | wilson | |
| Risk in group 2 | 0.195 | 0.169 | 0.225 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00833 | -0.0429 | 0.0247 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.957 | 0.803 | 1.14 | log | |
| Odds ratio, group 1 over group 2 | 0.948 | 0.762 | 1.18 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Alirocumab 150 mg Q2W than on Placebo Q2W | 120 | 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 mg Q2W | Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks. | 290 | 1,550 | EG001 |
| Group 2 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks. | 154 | 788 | 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 86 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
Source ClinicalTrials.gov
Trial
- Title
- Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)
- NCT number
- NCT01507831
- Phases
- PHASE3
- Conditions
- Hypercholesterolemia
- Interventions
- Placebo (for alirocumab), Alirocumab, Lipid-Modifying Therapy (LMT)
- Lead sponsor
- Sanofi
- Results first posted
- 2015-12-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01507831?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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