Alirocumab vs Placebo: deaths from any cause
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.0252 | 0.0222 | 0.0285 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0294 | 0.0262 | 0.033 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.00426 | -0.00893 | 0.000396 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.855 | 0.721 | 1.01 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.852 | 0.715 | 1.02 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer death from any cause on Alirocumab than on Placebo | 235 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Alirocumab | Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when LDL-C levels \>=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were \<25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were \<15 mg/dL (0.39 mmol/L). | 238 | 9,451 | EG001 | ClinicalTrials.gov |
| Group 2 | Placebo | Placebo (for alirocumab) SC injection Q2W added to stable LMT for up to 64 months. | 278 | 9,443 | EG000 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, all-cause mortality | ClinicalTrials.gov |
| Time frame | All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP). | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab | ClinicalTrials.gov |
| NCT number | NCT01663402 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Atherosclerotic Cardiovascular Disease | ClinicalTrials.gov |
| Interventions | Alirocumab, Placebo, LMT | ClinicalTrials.gov |
| Lead sponsor | Sanofi | ClinicalTrials.gov |
| Results first posted | 2019-03-18 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT01663402?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.