Comparison · NCT01982812-sae
Oral Levetiracetam vs Comparison Group: 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. Oral Levetiracetam vs Comparison Group: serious adverse events. Trial comparisons, record NCT01982812-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01982812-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 | 0.217 | 0.0966 | 0.419 | wilson | |
| Risk in group 2 | 0.381 | 0.208 | 0.591 | wilson | |
| Risk difference, group 1 minus group 2 | -0.164 | -0.406 | 0.102 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.571 | 0.221 | 1.47 | log | |
| Odds ratio, group 1 over group 2 | 0.451 | 0.12 | 1.7 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Oral Levetiracetam than on Comparison Group | 6.11 | 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 | Oral Levetiracetam | Oral Levetiracetam administered by NG tube.~Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days | 5 | 23 | EG000 |
| Group 2 | Comparison Group | 2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion~2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load | 8 | 21 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 1 month post enrollment
Source ClinicalTrials.gov
Trial
- Title
- A Safety and Feasibility Study of Enteral LVT vs. Standard of Care for Seizure Control in Pediatric CM
- NCT number
- NCT01982812
- Phases
- PHASE2
- Conditions
- Seizure, Epilepsy, Cerebral Malaria
- Interventions
- Oral Levetiracetam, Standard AED
- Lead sponsor
- University of Rochester
- Results first posted
- 2016-07-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01982812?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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