Comparison · NCT01958320-sae
Early Treatment vs Conservative Treatment: 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. Early Treatment vs Conservative Treatment: serious adverse events. Trial comparisons, record NCT01958320-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01958320-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 | 0.163 | 0.105 | 0.246 | wilson | |
| Risk in group 2 | 0.194 | 0.128 | 0.283 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0304 | -0.137 | 0.0755 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.843 | 0.466 | 1.53 | log | |
| Odds ratio, group 1 over group 2 | 0.812 | 0.395 | 1.67 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Early Treatment than on Conservative Treatment | 32.9 | 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 | Early Treatment | Infants randomized to the early treatment group will receive pharmacologic treatment of the PDA to produce PDA closure. Within 24-36 hr following the last treatment dose an echocardiogram will be obtained to document the degree of ductus closure or patency.~Echocardiograms will be obtained at 1) 10-14 days after study entry (if the PDA was open and of moderate size on the last echocardiogram), and 2) at the time of hospital discharge (if the PDA was open (any size) on the last echocardiogram). The echocardiogram obtained at discharge will be used to determine the need for outpatient follow-up.~pharmacologic treatment of the PDA: Following randomization, infants will be treated with medications used to produce PDA closure. | 17 | 104 | EG000 |
| Group 2 | Conservative Treatment | Infants randomized to the Conservative Treatment approach will receive no pharmacologic treatment of the PDA but will be followed to determine if they meet criteria for later PDA rescue treatment (Infants will be eligible for rescue treatment of their persistent PDA if they meet the rescue treatment criteria.)~Echocardiograms will be obtained at 1) 10-14 days after study entry (if the PDA was open and of moderate size on the last echocardiogram), and 2) at the time of hospital discharge (if the PDA was open (any size) on the last echocardiogram). The echocardiogram obtained at discharge will be used to determine the need for outpatient follow-up.~no pharmacologic treatment of the PDA: Following randomization, infants will NOT be treated with medications used to produce PDA closure (unless they develop rescue criteria at a later point in time). | 19 | 98 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- until hospital discharge (approximately 6 months unless death occurs first)
Source ClinicalTrials.gov
Trial
- Title
- Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus
- NCT number
- NCT01958320
- Phases
- PHASE2
- Conditions
- Patent Ductus Arteriosus, Surgery, Necrotizing Enterocolitis, Intestinal Perforation
- Interventions
- pharmacologic treatment of the PDA, no pharmacologic treatment of the PDA, NSAID
- Lead sponsor
- University of California, San Francisco
- Results first posted
- 2018-11-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01958320?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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