Comparison · NCT01266265-sae
Tyvaso vs Control: 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. Tyvaso vs Control: serious adverse events. Trial comparisons, record NCT01266265-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01266265-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 | 0.144 | 0.12 | 0.173 | wilson | |
| Risk in group 2 | 0.141 | 0.117 | 0.169 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00321 | -0.0344 | 0.0409 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.02 | 0.786 | 1.33 | log | |
| Odds ratio, group 1 over group 2 | 1.03 | 0.755 | 1.4 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Tyvaso than on Control | 311 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Tyvaso | The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.~inhaled prostacyclin: Tyvaso | 96 | 666 | EG000 |
| Group 2 | Control | The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care. | 94 | 667 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
Source ClinicalTrials.gov
Trial
- Title
- Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies
- NCT number
- NCT01266265
- Phases
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- inhaled prostacyclin, inhaled prostacyclin, prostacyclin, subcutaneous and intravenous prostacyclin, oral ERA, oral PDE5 inhibitors
- Lead sponsor
- United Therapeutics
- Results first posted
- 2016-02-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01266265?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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