Comparison · NCT02064868-sae
Serelaxin + Standard of Care vs Standard of Care (SOC): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Serelaxin + Standard of Care vs Standard of Care (SOC): serious adverse events. Trial comparisons, record NCT02064868-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02064868-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 | 0.124 | 0.109 | 0.14 | wilson | |
| Risk in group 2 | 0.12 | 0.1 | 0.143 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00408 | -0.0231 | 0.0297 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.03 | 0.832 | 1.29 | log | |
| Odds ratio, group 1 over group 2 | 1.04 | 0.811 | 1.33 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Serelaxin + Standard of Care than on Standard of Care (SOC) | 245 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard of care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Serelaxin + Standard of Care | Serelaxin (30 μg/kg/day) as continuous 48 hour intravenous infusion plus standard of care. | 214 | 1,729 | EG000 |
| Group 2 | Standard of Care (SOC) | All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc. | 107 | 894 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All Cause Mortality: 30 days (additional deaths are included which occurred after the clinical trial reporting period of 30 days for up to 8 months post randomization); Serious Adverse Events: 14 days; Other non-serious Adverse Events (AEs): 5 days
Source ClinicalTrials.gov
Trial
- Title
- Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients
- NCT number
- NCT02064868
- Phases
- PHASE3
- Conditions
- Acute Heart Failure (AHF)
- Interventions
- Serelaxin, Standard of Care
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2019-03-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02064868?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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