Comparison · NCT01332331-sae
Low Dose Ambrisentan vs High Dose Ambrisentan: 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. Low Dose Ambrisentan vs High Dose Ambrisentan: serious adverse events. Trial comparisons, record NCT01332331-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01332331-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 | 0.286 | 0.138 | 0.5 | wilson | |
| Risk in group 2 | 0.1 | 0.0279 | 0.301 | wilson | |
| Risk difference, group 1 minus group 2 | 0.186 | -0.0637 | 0.411 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.86 | 0.651 | 12.5 | log | |
| Odds ratio, group 1 over group 2 | 3.6 | 0.631 | 20.5 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Low Dose Ambrisentan than on High Dose Ambrisentan | 5.38 | 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 | Low Dose Ambrisentan | Participants received ambrisentan low dose tablet either 2.5 mg or 5 mg orally once daily for 24 weeks. | 6 | 21 | EG000 |
| Group 2 | High Dose Ambrisentan | Participants received ambrisentan high dose tablet either 5 mg, 7.5 mg or 10 mg orally once daily for 24 weeks. | 2 | 20 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 24 weeks
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Ambrisentan in Children 8-18yrs
- NCT number
- NCT01332331
- Phases
- PHASE2
- Conditions
- Hypertension, Pulmonary
- Interventions
- Ambrisentan - low dose, Ambrisentan - high dose
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2019-10-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01332331?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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