Comparison · NCT02585778-sae
Alirocumab 75 mg Q2W/Up to 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
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ConductScience Library. Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs Placebo Q2W: serious adverse events. Trial comparisons, record NCT02585778-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02585778-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 | 0.0901 | 0.0642 | 0.125 | wilson | |
| Risk in group 2 | 0.0941 | 0.0588 | 0.147 | wilson | |
| Risk difference, group 1 minus group 2 | -0.004 | -0.0633 | 0.0457 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.957 | 0.539 | 1.7 | log | |
| Odds ratio, group 1 over group 2 | 0.953 | 0.506 | 1.8 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Alirocumab 75 mg Q2W/Up to 150 mg Q2W than on Placebo Q2W | 250 | 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 Q2W/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. | 31 | 344 | EG000 |
| Group 2 | Placebo Q2W | Placebo (for alirocumab) SC injection Q2W added to stable, maximally tolerated dose of statin therapy with or without other LMT, insulin alone or with other antihyperglycemic drugs for 24 weeks. | 16 | 170 | 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 32) in the study regardless of seriousness or relationship to study drugs.
Source ClinicalTrials.gov
Trial
- Title
Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin)
- NCT number
- NCT02585778
- Phases
- PHASE3
- Conditions
- Hypercholesterolaemia
- Interventions
- Alirocumab, Placebo, Lipid-Modifying Therapy (LMT), Antihyperglycemic Drug
- Lead sponsor
- Sanofi
- Results first posted
- 2018-05-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02585778?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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