10 mg Empagliflozin 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 | 0.479 | 0.461 | 0.497 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.516 | 0.498 | 0.534 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.0369 | -0.0622 | -0.0116 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.928 | 0.882 | 0.977 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.863 | 0.779 | 0.955 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with a serious adverse event on 10 mg Empagliflozin than on Placebo | 27.1 | 16.1 | 86.3 | 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 | 10 mg Empagliflozin | 1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF). | 1,436 | 2,996 | EG001 | ClinicalTrials.gov |
| Group 2 | Placebo | 1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF). | 1,543 | 2,989 | EG000 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | [All-cause Mortality]: From study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved) | ClinicalTrials.gov |
| NCT number | NCT03057951 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Heart Failure | ClinicalTrials.gov |
| Interventions | Empagliflozin, Placebo | ClinicalTrials.gov |
| Lead sponsor | Boehringer Ingelheim | ClinicalTrials.gov |
| Results first posted | 2022-06-06 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT03057951?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.