Comparison · NCT02452476-sae
CHF5633 vs Poractant Alfa: 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. CHF5633 vs Poractant Alfa: serious adverse events. Trial comparisons, record NCT02452476-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02452476-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 | 0.339 | 0.231 | 0.466 | wilson | |
| Risk in group 2 | 0.345 | 0.236 | 0.473 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00584 | -0.173 | 0.162 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.983 | 0.595 | 1.63 | log | |
| Odds ratio, group 1 over group 2 | 0.974 | 0.454 | 2.09 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on CHF5633 than on Poractant Alfa | 171 | 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 | CHF5633 | Single dose within 24 hours from birth~CHF5633: Rescue treatment (if needed) | 20 | 59 | EG000 |
| Group 2 | Poractant Alfa | Single dose within 24 hours from birth~Poractant alfa: Rescue treatment (if needed) | 20 | 58 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Source ClinicalTrials.gov
Trial
- Title
- A Double Blind, Randomized, Controlled Study to Evaluate CHF 5633 (Synthetic Surfactant) and Poractant Alfa in Neonates With Respiratory Distress Syndrome (RDS) (POC)
- NCT number
- NCT02452476
- Phases
- PHASE2
- Conditions
- Respiratory Distress Syndrome, Newborn
- Interventions
- CHF5633, Poractant alfa
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Results first posted
- 2021-06-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02452476?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
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