Comparison · NCT01105091-sae
ACT-385781A (Epoprostenol for Injection) vs Flolan® (Epoprostenol Sodium) for Injection: 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. ACT-385781A (Epoprostenol for Injection) vs Flolan® (Epoprostenol Sodium) for Injection: serious adverse events. Trial comparisons, record NCT01105091-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01105091-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 | 0.3 | 0.145 | 0.519 | wilson | |
| Risk in group 2 | 0.2 | 0.0567 | 0.51 | wilson | |
| Risk difference, group 1 minus group 2 | 0.1 | -0.246 | 0.362 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.5 | 0.367 | 6.14 | log | |
| Odds ratio, group 1 over group 2 | 1.71 | 0.278 | 10.6 | log | |
| Number needed to harm, for one more participant with a serious adverse event on ACT-385781A (Epoprostenol for Injection) than on Flolan® (Epoprostenol Sodium) for Injection | 10 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | ACT-385781A (Epoprostenol for Injection) | The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability. | 6 | 20 | EG000 |
| Group 2 | Flolan® (Epoprostenol Sodium) for Injection | The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability | 2 | 10 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Screening to day 28 for treatment-emergent (TE) adverse events (AEs) during dosing inpatient hospitalization and during outpatient period up to day 28 (EOT). TE serious AEs (SAEs) up to 30 days post study drug.
Source ClinicalTrials.gov
Trial
- Title
- Epoprostenol for Injection in Pulmonary Arterial Hypertension
- NCT number
- NCT01105091
- Phases
- PHASE4
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- ACT-385781A (Actelion Epoprostenol), Flolan®
- Lead sponsor
- Actelion
- Results first posted
- 2012-08-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01105091?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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