Comparison · NCT03169881-sae
Darbepoetin 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. Darbepoetin vs Placebo: serious adverse events. Trial comparisons, record NCT03169881-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03169881-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 | 0.269 | 0.223 | 0.32 | wilson | |
| Risk in group 2 | 0.283 | 0.237 | 0.334 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0141 | -0.0829 | 0.0551 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.95 | 0.739 | 1.22 | log | |
| Odds ratio, group 1 over group 2 | 0.932 | 0.659 | 1.32 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Darbepoetin than on Placebo | 71 | 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 | Darbepoetin | Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age, intravenously when the infant had intravenous access, otherwise subcutaneously | 85 | 316 | EG000 |
| Group 2 | Placebo | Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose | 92 | 325 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Source ClinicalTrials.gov
Trial
- Title
- Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants
- NCT number
- NCT03169881
- Phases
- PHASE3
- Conditions
- Neurocognitive, Neuroprotective, Neonatal, Neurodevelopmental Impairment
- Interventions
- Darbepoetin, Placebo
- Lead sponsor
- NICHD Neonatal Research Network
- Results first posted
- 2024-10-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03169881?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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