Comparison · NCT01743001-sae
Macitentan 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 vs Placebo: serious adverse events. Trial comparisons, record NCT01743001-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01743001-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 | 0.0614 | 0.0301 | 0.121 | wilson | |
| Risk in group 2 | 0.0179 | 0.00491 | 0.0628 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0435 | -0.0112 | 0.105 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.44 | 0.73 | 16.2 | log | |
| Odds ratio, group 1 over group 2 | 3.6 | 0.731 | 17.7 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Macitentan than on Placebo | 23 | 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 | Subjects receive macitentan 10 mg orally to be taken once daily. 114 subjects were exposed to Macitentan 10 mg for 15.93 weeks on average. | 7 | 114 | EG000 |
| Group 2 | Placebo | Subjects receive macitentan-matching placebo orally to be taken once daily. 112 subjects were exposed to placebo for 15.96 weeks on average. | 2 | 112 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
A safety follow-up visit was required 30 days after end of treatment period at Week 16. Subjects who prematurely discontinued treatment prior to Week 16 were required to perform a premature end-of-treatment visit no later than 7 days after last dose of study treatment and then followed by the 30 day safety follow-up visit.
Source ClinicalTrials.gov
Trial
- Title
- Clinical Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome
- NCT number
- NCT01743001
- Phases
- PHASE3
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Macitentan 10 mg, Placebo
- Lead sponsor
- Actelion
- Results first posted
- 2018-01-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01743001?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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