Comparison · NCT02554903-sae
Macitentan 10 Milligrams (mg) 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. Macitentan 10 Milligrams (mg) vs Placebo: serious adverse events. Trial comparisons, record NCT02554903-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02554903-sae
On this page
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 | 0.571 | 0.391 | 0.735 | wilson | |
| Risk in group 2 | 0.552 | 0.375 | 0.716 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0197 | -0.224 | 0.26 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.04 | 0.655 | 1.64 | log | |
| Odds ratio, group 1 over group 2 | 1.08 | 0.38 | 3.09 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Macitentan 10 Milligrams (mg) than on Placebo | 50.8 | 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 | Macitentan 10 Milligrams (mg) | Participants (with pulmonary hypertension \[PH\] after a left ventricular assist device \[LVAD\] implantation) received macitentan 10 mg orally once daily up to Week 12. | 16 | 28 | EG000 |
| Group 2 | Placebo | Participants (with PH after LVAD implantation) received matching placebo orally once daily up to Week 12. | 16 | 29 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 16 weeks
Source ClinicalTrials.gov
Trial
- Title
- Clinical Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation
- NCT number
- NCT02554903
- Phases
- PHASE2
- Conditions
- Pulmonary Hypertension
- Interventions
- Macitentan 10mg, Placebo sugar pill
- Lead sponsor
- Actelion
- Results first posted
- 2021-04-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02554903?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT02554903-sae