Comparison · NCT02630316-sae
Active Inhaled Treprostinil 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. Active Inhaled Treprostinil vs Placebo: serious adverse events. Trial comparisons, record NCT02630316-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02630316-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 | 0.233 | 0.175 | 0.304 | wilson | |
| Risk in group 2 | 0.258 | 0.197 | 0.33 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0245 | -0.117 | 0.0688 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.905 | 0.618 | 1.32 | log | |
| Odds ratio, group 1 over group 2 | 0.876 | 0.529 | 1.45 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Active Inhaled Treprostinil than on Placebo | 40.7 | 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 | Active Inhaled Treprostinil | Active Treprostinil for inhalation solution (0.6 mg/mL) delivered via an ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath. Inhaled four times daily and titrated up to a maximum of 12 breaths four times daily~Inhaled Treprostinil: Inhaled treprostinil (6 mcg/breath) administered four times daily | 38 | 163 | EG001 |
| Group 2 | Placebo | Matching placebo inhaled using an ultrasonic nebulizer four times daily~Placebo: Placebo administered four times daily | 42 | 163 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- AEs were recorded throughout the course of the study from the time that each subject signed the ICF until all study assessments were completed (16 weeks).
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy of Inhaled Treprostinil in Adult PH With ILD Including CPFE
- NCT number
- NCT02630316
- Phases
- PHASE2, PHASE3
- Conditions
- Pulmonary Hypertension, Interstitial Lung Disease, Combined Pulmonary Fibrosis and Emphysema
- Interventions
- Inhaled Treprostinil, Placebo
- Lead sponsor
- United Therapeutics
- Results first posted
- 2021-07-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02630316?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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