Comparison · NCT00391443-sae
Bosentan 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. Bosentan vs Placebo: serious adverse events. Trial comparisons, record NCT00391443-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00391443-sae
On this page
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 | 0.318 | 0.274 | 0.365 | wilson | |
| Risk in group 2 | 0.354 | 0.292 | 0.421 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0363 | -0.116 | 0.0411 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.897 | 0.712 | 1.13 | log | |
| Odds ratio, group 1 over group 2 | 0.85 | 0.597 | 1.21 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Bosentan than on Placebo | 27.5 | 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 | Bosentan | Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight \> 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight \< 40 kg (90 lb): 62.5 mg b.i.d. | 129 | 406 | EG001 |
| Group 2 | Placebo | Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight \> 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight \< 40 kg (90 lb): 62.5 mg b.i.d. | 74 | 209 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All treatment-emergent adverse events occurring after the start of study treatment and within 24 hours after the end of study treatment
Source ClinicalTrials.gov
Trial
- Title
- BUILD 3: Bosentan Use in Interstitial Lung Disease
- NCT number
- NCT00391443
- Phases
- PHASE3
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Bosentan, Placebo
- Lead sponsor
- Actelion
- Results first posted
- 2012-05-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00391443?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT00391443-sae