Comparison · NCT04600921-sae
Ertugliflozin 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. Ertugliflozin vs Placebo: serious adverse events. Trial comparisons, record NCT04600921-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04600921-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 | 0.4 | 0.234 | 0.593 | wilson | |
| Risk in group 2 | 0.7 | 0.521 | 0.833 | wilson | |
| Risk difference, group 1 minus group 2 | -0.3 | -0.513 | -0.0372 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.571 | 0.335 | 0.975 | log | |
| Odds ratio, group 1 over group 2 | 0.286 | 0.0934 | 0.874 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Ertugliflozin than on Placebo | 3.33 | 1.95 | 26.9 | 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 | Ertugliflozin | The subject will receive Ertugliflozin 5mg.~Ertugliflozin 5 mg: The subject will receive Ertugliflozin 5mg orally once daily for 52 weeks. | 10 | 25 | EG000 |
| Group 2 | Placebo | The subject will receive Placebo 5mg.~Placebo 5mg: The subject will receive Placebo 5mg orally daily for 52 weeks. | 21 | 30 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events are recorded from baseline to 56 weeks
Source ClinicalTrials.gov
Trial
- Title
- Ertugliflozin to Reduce Arrhythmic Burden in ICD/CRT patientS (ERASe-Trial) - a Phase III Study
- NCT number
- NCT04600921
- Phases
- PHASE3
- Conditions
- Heart Failure With Reduced Ejection Fraction, Heart Failure With Mid Range Ejection Fraction, Implantable Cardioverter-Defibrillators, Cardiac Resynchronization Therapy
- Interventions
- Ertugliflozin 5 mg, Placebo 5mg
- Lead sponsor
- Medical University of Graz
- Results first posted
- 2025-06-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04600921?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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