Comparison · NCT01908699-sae
Esuberaprost 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. Esuberaprost vs Placebo: serious adverse events. Trial comparisons, record NCT01908699-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01908699-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 | 0.547 | 0.464 | 0.628 | wilson | |
| Risk in group 2 | 0.574 | 0.49 | 0.654 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0261 | -0.142 | 0.0906 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.955 | 0.774 | 1.18 | log | |
| Odds ratio, group 1 over group 2 | 0.9 | 0.558 | 1.45 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Esuberaprost than on Placebo | 38.3 | 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 | Esuberaprost | Participants received 1 tablet of esuberaprost (BPS-314d-MR) 14.2 micrograms (mcg) orally 4 times daily (QID) (total daily dose: 56.8 mcg) in conjunction with inhaled treprostinil for 2 weeks. After 2 weeks, esuberaprost dose was increased to 2 tablets (14.2 mcg each) QID (total daily dose: 113.6 mcg). Participants who were unable to tolerate the 2 tablets QID dosing regimen were permitted to continue on 1 tablet QID during the study treatment. | 75 | 137 | EG000 |
| Group 2 | Placebo | Participants received 1 or 2 tablets of placebo matched to esuberaprost orally QID in conjunction with inhaled treprostinil. | 78 | 136 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 144 weeks
Source ClinicalTrials.gov
Trial
- Title
- Beraprost-314d Added-on to Tyvaso® (BEAT)
- NCT number
- NCT01908699
- Phases
- PHASE3
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Beraprost Sodium 314d Modified Release Tablets, Placebo
- Lead sponsor
- Lung Biotechnology PBC
- Results first posted
- 2020-02-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01908699?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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