Comparison · NCT01338415-861bd64a
Bosentan 2mg/kg b.i.d. vs Bosentan 2mg/kg t.i.d.: Treatment Emergent Adverse Events (AEs) up to 7 Days After Permanent Study Drug Discontinuation
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. Bosentan 2mg/kg b.i.d. vs Bosentan 2mg/kg t.i.d.: Treatment Emergent Adverse Events (AEs) up to 7 Days After Permanent Study Drug Discontinuation. Trial comparisons, record NCT01338415-861bd64a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01338415-861bd64a
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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 | 0.879 | 0.727 | 0.952 | wilson | |
| Risk in group 2 | 0.839 | 0.674 | 0.929 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0401 | -0.137 | 0.221 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.05 | 0.858 | 1.28 | log | |
| Odds ratio, group 1 over group 2 | 1.39 | 0.338 | 5.75 | log | |
| Number needed to treat, for one more participant with the outcome on Bosentan 2mg/kg b.i.d. than on Bosentan 2mg/kg t.i.d. | 25 | 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 | Bosentan 2mg/kg b.i.d. | Patients received 2 milligrams per kilogram (mg/kg) bosentan twice daily (b.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study. | 29 | 33 | OG000 |
| Group 2 | Bosentan 2mg/kg t.i.d. | Patients received 2 mg/kg bosentan 3 times a day (t.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study. | 26 | 31 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Treatment Emergent Adverse Events (AEs) up to 7 Days After Permanent Study Drug Discontinuation
- Description
This is the total number of subjects with at least one adverse event (serious or not serious) whether or not causally related to the study drug and presented cumulatively in the FUTURE 3 and FUTURE 3 Extension study. NOTE: FUTURE 3 extension study was exploratory and no primary efficacy and safety endpoints were defined in the protocol. So, this safety outcome measure was selected and reported as primary endpoint here.
- Time frame
- Up to 62 weeks in average
- Population
The analysis was performed on the Safety population analysis set, including all patients who received at least one dose of study treatment and evaluated according to the study treatment that they received.
Source ClinicalTrials.gov
Trial
- Title
- FUTURE 3 Study Extension
- NCT number
- NCT01338415
- Phases
- PHASE3
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Bosentan
- Lead sponsor
- Actelion
- Results first posted
- 2017-12-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01338415?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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