Comparison · NCT03541603-sae
Levosimendan 2.5mg/mL Injectable Solution vs Matching 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. Levosimendan 2.5mg/mL Injectable Solution vs Matching Placebo: serious adverse events. Trial comparisons, record NCT03541603-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03541603-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 | 0.167 | 0.0584 | 0.392 | wilson | |
| Risk in group 2 | 0.0526 | 0.00935 | 0.246 | wilson | |
| Risk difference, group 1 minus group 2 | 0.114 | -0.108 | 0.344 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.17 | 0.362 | 27.7 | log | |
| Odds ratio, group 1 over group 2 | 3.6 | 0.338 | 38.3 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Levosimendan 2.5mg/mL Injectable Solution than on Matching Placebo | 8.77 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Levosimendan 2.5mg/mL Injectable Solution | 0.075 - 0.1µg/kg/min for 24 hrs (weekly)~Levosimendan: A sterile 2.5 mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion | 3 | 18 | EG000 |
| Group 2 | Matching Placebo | 0.075 - 0.1µg/kg/min for 24 hrs (weekly)~Matching Placebo: A sterile 2.5mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion | 1 | 19 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 6 weeks
Source ClinicalTrials.gov
Trial
- Title
- Hemodynamic Evaluation of Levosimendan in Patients With PH-HFpEF
- NCT number
- NCT03541603
- Phases
- PHASE2
- Conditions
- Hypertension Pulmonary Secondary, Heart Failure, Right Sided, Heart Failure With Normal Ejection Fraction
- Interventions
- Levosimendan, Matching Placebo
- Lead sponsor
- Tenax Therapeutics, Inc.
- Results first posted
- 2024-05-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03541603?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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