Ezetimide/Simvastatin vs Simvastatin: 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 | 0.401 | 0.391 | 0.412 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.402 | 0.392 | 0.412 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.000549 | -0.0148 | 0.0137 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.999 | 0.964 | 1.03 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.998 | 0.94 | 1.06 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with a serious adverse event on Ezetimide/Simvastatin than on Simvastatin | 1,820 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
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 | Source |
|---|---|---|---|---|---|---|
| Group 1 | Ezetimide/Simvastatin | One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day. | 3,640 | 9,067 | EG000 | ClinicalTrials.gov |
| Group 2 | Simvastatin | One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day. | 3,649 | 9,077 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | up to 30 days after last dose of study drug (Up to approximately 9 years maximum) | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (P04103) | ClinicalTrials.gov |
| NCT number | NCT00202878 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Hypercholesterolemia, Myocardial Infarction | ClinicalTrials.gov |
| Interventions | ezetimibe/simvastatin, simvastatin, Placebo for simvastatin 40 mg, Placebo for ezetimibe 10 mg/simvastatin 40 mg combination | ClinicalTrials.gov |
| Lead sponsor | Organon and Co | ClinicalTrials.gov |
| Results first posted | 2015-09-30 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT00202878?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.