Comparison · NCT01720667-sae
Intravenous Phenobarbital vs Intravenous Levetiracetam: 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. Intravenous Phenobarbital vs Intravenous Levetiracetam: serious adverse events. Trial comparisons, record NCT01720667-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01720667-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 | 0.0156 | 0.00276 | 0.0833 | wilson | |
| Risk difference, group 1 minus group 2 | 0.103 | 0.00809 | 0.235 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 7.62 | 0.922 | 62.9 | log | |
| Odds ratio, group 1 over group 2 | 8.51 | 0.958 | 75.7 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Intravenous Phenobarbital than on Intravenous Levetiracetam | 9.67 | 4.26 | 124 | from the risk difference interval |
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 | Intravenous Phenobarbital | Intravenous phenobarbital 20 mg/kg loading dose. If electrographic seizures persisted or recurred 15 minutes following completion of the infusion, subjects received a further 20 mg/kg PHB infusion over 15 minutes. If electrographic seizures persisted or recurred 15 minutes following completion of the second infusion, the subject was then treated with LEV 40 mg/kg first. Another dose of 20 mg/kg PHB given if seizures persist. Unresponsive subjects exit the study. All subjects received maintenance 1.5 mg/kg PHB mg/kg/dose given IV q8 hours continued for five days. | 5 | 42 | EG000 |
| Group 2 | Intravenous Levetiracetam | Intravenous levetiracetam 40 - 60 mg/kg loading dose. If electrographic seizures persisted or recurred 15 minutes following completion of the infusion, subjects received a further 20 mg/kg LEV infusion over 15 minutes. If electrographic seizures persisted or recurred 15 minutes following completion of the second infusion, the subject was then treated with PHB 20 mg/kg. Another dose of 20 mg/kg PHB given if seizures persist. Unresponsive subjects exit the study. All subjects received maintenance LEV 10 mg/kg/dose given IV q8 hours continued for five days. | 1 | 64 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 5 days after treatment
Source ClinicalTrials.gov
Trial
- Title
- Efficacy of Intravenous Levetiracetam in Neonatal Seizures
- NCT number
- NCT01720667
- Phases
- PHASE1, PHASE2
- Conditions
- Neonatal Seizures
- Interventions
- Intravenous levetiracetam, Intravenous phenobarbital
- Lead sponsor
- Richard H. Haas
- Results first posted
- 2019-08-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01720667?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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