Comparison · NCT01223352-sae
Bosentan 2 mg/kg t.i.d vs Bosentan 2 mg/kg b.i.d: 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 2 mg/kg t.i.d vs Bosentan 2 mg/kg b.i.d: serious adverse events. Trial comparisons, record NCT01223352-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01223352-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 | 0.194 | 0.0919 | 0.363 | wilson | |
| Risk in group 2 | 0.121 | 0.0482 | 0.273 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0723 | -0.111 | 0.257 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.6 | 0.497 | 5.13 | log | |
| Odds ratio, group 1 over group 2 | 1.74 | 0.441 | 6.87 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Bosentan 2 mg/kg t.i.d than on Bosentan 2 mg/kg b.i.d | 13.8 | 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 2 mg/kg t.i.d | Patients received 2 mg/kg of bosentan 3 times a day (morning, afternoon, evening) for at least 0.4 week and up to 28.7 weeks | 6 | 31 | EG000 |
| Group 2 | Bosentan 2 mg/kg b.i.d | Patients received 2 mg/kg of bosentan twice daily (morning and evening) for at least 6 weeks and up to 26.4 weeks | 4 | 33 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the first dose of study treatment on Day 1 up to 7 days after treatment discontinuation, i.e. up to Week 25 on average
Source ClinicalTrials.gov
Trial
- Title
- Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension
- NCT number
- NCT01223352
- Phases
- PHASE3
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- bosentan
- Lead sponsor
- Actelion
- Results first posted
- 2017-06-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01223352?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/NCT01223352-sae