AMR101 vs Placebo: serious adverse events
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 | 0.306 | 0.292 | 0.32 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.307 | 0.293 | 0.321 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.000414 | -0.0204 | 0.0196 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.999 | 0.936 | 1.07 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.998 | 0.908 | 1.1 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with a serious adverse event on AMR101 than on Placebo | 2,410 | 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 | AMR101 | AMR101: Parallel Assignment | 1,252 | 4,089 | EG000 | ClinicalTrials.gov |
| Group 2 | Placebo | Placebo: Parallel Assignment | 1,254 | 4,090 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | Up to maximum duration of approximate 6 years from first dose of study treatment until end of study treatment plus 30 days post treatment. | 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.