Comparison · NCT02261883-sae
IV Remodulin 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. IV Remodulin vs Placebo: serious adverse events. Trial comparisons, record NCT02261883-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02261883-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 | 0.4 | 0.219 | 0.613 | wilson | |
| Risk in group 2 | 0.143 | 0.0498 | 0.346 | wilson | |
| Risk difference, group 1 minus group 2 | 0.257 | -0.0153 | 0.49 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.8 | 0.863 | 9.09 | log | |
| Odds ratio, group 1 over group 2 | 4 | 0.88 | 18.2 | log | |
| Number needed to harm, for one more participant with a serious adverse event on IV Remodulin than on Placebo | 3.89 | 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 | IV Remodulin | The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.~IV Remodulin: Treprostinil is a chemically stable tricyclic analogue of prostacyclin. | 8 | 20 | EG000 |
| Group 2 | Placebo | The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.~Placebo: Sodium citrate USP/EP/JP, sodium chloride USP/EP/JP, sodium hydroxide pellets, metacresol, and citric acid (anhydrous). | 3 | 21 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
Source ClinicalTrials.gov
Trial
- Title
- Remodulin as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn
- NCT number
- NCT02261883
- Phases
- PHASE2
- Conditions
- Persistent Pulmonary Hypertension of the Newborn
- Interventions
- IV Remodulin, Placebo
- Lead sponsor
- United Therapeutics
- Results first posted
- 2024-03-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02261883?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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