AMR101 vs Placebo: Composite of CV Death, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.
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 | 0.112 | 0.103 | 0.122 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.148 | 0.138 | 0.159 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.0359 | -0.0505 | -0.0213 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.758 | 0.676 | 0.848 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.727 | 0.638 | 0.828 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on AMR101 than on Placebo | 27.8 | 19.8 | 46.9 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | AMR101 | AMR101: Parallel Assignment | 459 | 4,089 | OG000 | ClinicalTrials.gov |
| Group 2 | Placebo | Placebo: Parallel Assignment | 606 | 4,090 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Composite of CV Death, Nonfatal MI (Including Silent MI), or Nonfatal Stroke. | ClinicalTrials.gov |
| Description | The key secondary outcome measure was the number of patients with a first occurrence of any component of the composite of CV death, nonfatal MI (including silent MI), or nonfatal stroke during the follow-up period. | ClinicalTrials.gov |
| Time frame | Total follow-up time of up to approximately 6 years. | ClinicalTrials.gov |
| Population | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin | ClinicalTrials.gov |
| NCT number | NCT01492361 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Cardiovascular Diseases | ClinicalTrials.gov |
| Interventions | AMR101, Placebo, Statin therapy | ClinicalTrials.gov |
| Lead sponsor | Amarin Pharma Inc. | ClinicalTrials.gov |
| Results first posted | 2022-04-14 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT01492361?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.