Comparison · NCT01644188-sae
Alirocumab 75/Up to 150 mg Q2W vs Ezetimibe 10 mg: 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/Up to 150 mg Q2W vs Ezetimibe 10 mg: serious adverse events. Trial comparisons, record NCT01644188-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01644188-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 | 0.259 | 0.222 | 0.3 | wilson | |
| Risk in group 2 | 0.249 | 0.199 | 0.307 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00991 | -0.0592 | 0.0749 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.04 | 0.797 | 1.36 | log | |
| Odds ratio, group 1 over group 2 | 1.05 | 0.738 | 1.5 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Alirocumab 75/Up to 150 mg Q2W than on Ezetimibe 10 mg | 101 | 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/Up to 150 mg Q2W | Participants exposed to Alirocumab 75 /up to 150 mg Q2W added to stable LMT (mean exposition of 90 weeks). | 124 | 479 | EG000 |
| Group 2 | Ezetimibe 10 mg | Participants exposed to Ezetimibe 10 mg added to stable LMT (mean exposition of 90 weeks). | 60 | 241 | EG001 |
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 final visit (Week 112) in the study regardless of seriousness or relationship to study drugs.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)
- NCT number
- NCT01644188
- Phases
- PHASE3
- Conditions
- Hypercholesterolemia
- Interventions
- Alirocumab, Placebo (for alirocumab), Ezetimibe, Placebo (for ezetimibe), Lipid Modifying Therapy (LMT)
- Lead sponsor
- Sanofi
- Results first posted
- 2015-11-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01644188?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/NCT01644188-sae