Comparison · NCT03057977-sae
10 mg Empagliflozin vs Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. 10 mg Empagliflozin vs Placebo: serious adverse events. Trial comparisons, record NCT03057977-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03057977-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.414 | 0.392 | 0.437 | wilson | |
| Risk in group 2 | 0.481 | 0.458 | 0.504 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0666 | -0.0983 | -0.0346 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.862 | 0.802 | 0.926 | log | |
| Odds ratio, group 1 over group 2 | 0.764 | 0.671 | 0.869 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on 10 mg Empagliflozin than on Placebo | 15 | 10.2 | 28.9 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 10 mg Empagliflozin | Film-coated tablet of 10 milligram (mg) Empagliflozin was administered orally once daily. | 772 | 1,863 | EG001 |
| Group 2 | Placebo | 1 film-coated tablet of matching placebo was administered orally once daily. | 896 | 1,863 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first intake of study medication until end of planned treatment period + 7 days (Residual Effect Period), up to 1047 days.
Source ClinicalTrials.gov
Trial
- Title
- EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced)
- NCT number
- NCT03057977
- Phases
- PHASE3
- Conditions
- Heart Failure
- Interventions
- Empagliflozin, Placebo
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2021-05-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03057977?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- 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
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone 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.
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