Empagliflozin 10 mg 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 | 0.237 | 0.222 | 0.252 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.247 | 0.233 | 0.262 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.0106 | -0.0315 | 0.0103 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.957 | 0.878 | 1.04 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.944 | 0.842 | 1.06 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with a serious adverse event on Empagliflozin 10 mg than on Placebo | 94.5 | 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 | Empagliflozin 10 mg | Patients with an acute myocardial infarction event took, on top of standard of care, one empagliflozin (Jardiance®) 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water. | 765 | 3,234 | EG001 | ClinicalTrials.gov |
| Group 2 | Placebo | Patients with an acute myocardial infarction event took, on top of standard of care, one placebo matching-empagliflozin 10 milligrams (mg) film-coated tablet, orally, once daily, at the same time every morning, with a glass of water. | 798 | 3,229 | EG000 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | All-cause mortality - From first drug administration until individual day of trial completion. Up to 1004 days. Adverse event reporting - From first study drug administration to last study drug administration plus 7 days (residual effect period). Up to 1004 days. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | EMPACT-MI: A Study to Test Whether Empagliflozin Can Lower the Risk of Heart Failure and Death in People Who Had a Heart Attack (Myocardial Infarction) | ClinicalTrials.gov |
| NCT number | NCT04509674 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Myocardial Infarction | ClinicalTrials.gov |
| Interventions | Empagliflozin, Placebo | ClinicalTrials.gov |
| Lead sponsor | Boehringer Ingelheim | ClinicalTrials.gov |
| Results first posted | 2025-01-07 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT04509674?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.