Comparison · NCT01089504-sae
Phenobarbital 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. Phenobarbital vs Placebo: serious adverse events. Trial comparisons, record NCT01089504-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01089504-sae
On this page
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 | 0.125 | 0.0224 | 0.471 | wilson | |
| Risk in group 2 | 0.2 | 0.0362 | 0.624 | wilson | |
| Risk difference, group 1 minus group 2 | -0.075 | -0.512 | 0.308 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.625 | 0.0495 | 7.9 | log | |
| Odds ratio, group 1 over group 2 | 0.571 | 0.0276 | 11.8 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Phenobarbital than on Placebo | 13.3 | 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 | Phenobarbital | Phenobarbital, 4-5 mg/kg/day, for 4 months~phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months | 1 | 8 | EG000 |
| Group 2 | Placebo | Placebo in a volume equivalent to active drug for 4 months~placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months | 1 | 5 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Prophylactic Phenobarbital After Neonatal Seizures
- NCT number
- NCT01089504
- Phases
- PHASE4
- Conditions
- Neonatal Seizures
- Interventions
- phenobarbital, placebo
- Lead sponsor
- University of Rochester
- Results first posted
- 2016-02-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01089504?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
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01089504-sae