Comparison · NCT01709409-sae
Curosurf (Group 1) vs BLES (Group 2): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Curosurf (Group 1) vs BLES (Group 2): serious adverse events. Trial comparisons, record NCT01709409-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01709409-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 | 0.119 | 0.0519 | 0.25 | wilson | |
| Risk in group 2 | 0.244 | 0.142 | 0.387 | wilson | |
| Risk difference, group 1 minus group 2 | -0.125 | -0.283 | 0.0407 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.487 | 0.185 | 1.28 | log | |
| Odds ratio, group 1 over group 2 | 0.418 | 0.132 | 1.33 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Curosurf (Group 1) than on BLES (Group 2) | 7.97 | 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 | Curosurf (Group 1) | Surfactant(Curosurf in this arm) was given for treatment of established RDS. The treatment dose for Curosurf® was 2.5 ml/kg (200mg/kg) for the first dose and 1.25 ml/kg (100mg/kg) for repeat doses, given by endotracheal method. There was a maximum of 3 doses in the study. | 5 | 42 | EG000 |
| Group 2 | BLES (Group 2) | Surfactant(BLES in this arm) was given for treatment of established RDS. The treatment dose for BLES was 5 ml/kg. given by endotracheal method. There was a maximum of 3 doses in the study. | 11 | 45 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- A Multi-center Trial to Determine if Curosurf® Reduces the Duration of Mechanical Ventilation in Very Preterm Infants
- NCT number
- NCT01709409
- Phases
- PHASE3
- Conditions
- Respiratory Distress Syndrome
- Interventions
- Curosurf-Group1, BLES-group 2
- Lead sponsor
- Ottawa Hospital Research Institute
- Results first posted
- 2017-10-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01709409?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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