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 | 0.33 | 0.314 | 0.346 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.353 | 0.337 | 0.37 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.0235 | -0.0463 | -0.000638 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.933 | 0.873 | 0.998 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.901 | 0.814 | 0.997 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with a serious adverse event on Empagliflozin 10 mg than on Placebo | 42.6 | 21.6 | 1,570 | 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 | Empagliflozin 10 mg | Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily 10 milligram (mg) film-coated tablets of empagliflozin. | 1,089 | 3,304 | EG001 | ClinicalTrials.gov |
| Group 2 | Placebo | Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily film-coated tablets of placebo to match empagliflozin. | 1,167 | 3,305 | EG000 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | All-cause Mortality: From randomisation until end of study, up to 1869 days. Adverse events reporting: From randomisation until 7 days (Residual Effect Period) after the last drug intake, up to 1147 days. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin) | ClinicalTrials.gov |
| NCT number | NCT03594110 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Chronic Kidney Disease | ClinicalTrials.gov |
| Interventions | Empagliflozin, Matching placebo | ClinicalTrials.gov |
| Lead sponsor | Boehringer Ingelheim | ClinicalTrials.gov |
| Results first posted | 2023-07-27 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT03594110?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.