Comparison · NCT02290613-sae
Ambrisentan Verum 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. Ambrisentan Verum vs Placebo: serious adverse events. Trial comparisons, record NCT02290613-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02290613-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 | 0.0526 | 0.00935 | 0.246 | wilson | |
| Risk in group 2 | 0.263 | 0.118 | 0.488 | wilson | |
| Risk difference, group 1 minus group 2 | -0.211 | -0.439 | 0.0315 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.2 | 0.0257 | 1.55 | log | |
| Odds ratio, group 1 over group 2 | 0.156 | 0.0163 | 1.49 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Ambrisentan Verum than on Placebo | 4.75 | 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 | Ambrisentan Verum | Study medication will be ambrisentan 10 mg (starting with 5 mg in the beginning of the study and then up-titrated to 10 mg/die).~Ambrisentan: Titration:~As common practice of the clinic, the patient will adapt the dose from 5 mg to 10 mg after 1 to 4 weeks according to tolerability and after consultation (by phone or personally) with one of the investigators.~Additionally, at each study visit the investigator needs to decide, based on the patient's well-being, patients´ assessment, safety parameters, and tolerance of ambrisentan, if the study medication should be modified. The respective decision (increase, maintain or decrease dose) must be documented.~Maximum dose allowed: not to exceed 10 mg/die.~Administration:~Ambrisentan and placebo will be administered orally with or without food intake. | 1 | 19 | EG000 |
| Group 2 | Placebo | Placebo tablet~Placebo: Placebo tablet (one to two tablets corresponding to one to two verum tablets) | 5 | 19 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- adverse Events were collected throughout the study from baseline to the 6 month-assessment and 30 days follow-up.
Source ClinicalTrials.gov
Trial
- Title
- Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH)
- NCT number
- NCT02290613
- Phases
- PHASE2
- Conditions
- Systemic Sclerosis, Pulmonary Hypertension
- Interventions
- Ambrisentan, Placebo
- Lead sponsor
- Heidelberg University
- Results first posted
- 2020-04-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02290613?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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