Comparison · NCT03340064-sae
Levetiracetam: Adjunctive Therapy vs Levetiracetam: Monotherapy: 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. Levetiracetam: Adjunctive Therapy vs Levetiracetam: Monotherapy: serious adverse events. Trial comparisons, record NCT03340064-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03340064-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 | 0.563 | 0.393 | 0.718 | wilson | |
| Risk in group 2 | 0.333 | 0.0968 | 0.7 | wilson | |
| Risk difference, group 1 minus group 2 | 0.229 | -0.175 | 0.512 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.69 | 0.523 | 5.45 | log | |
| Odds ratio, group 1 over group 2 | 2.57 | 0.41 | 16.1 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Levetiracetam: Adjunctive Therapy than on Levetiracetam: Monotherapy | 4.36 | 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 | Levetiracetam: Adjunctive Therapy | Participants aged 1 month to less than (\<) 6 months received Levetiracetam (LEV) 14 milligram per kilogram per day (mg/kg/day) as adjunctive therapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged greater than or equal to (≥) 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till program discontinued. The dose down-titrated during 4 weeks Interval at the discretion of Investigator. | 18 | 32 | EG000 |
| Group 2 | Levetiracetam: Monotherapy | Participants aged 1 month to \< 6 months received LEV 14 mg/kg/day as monotherapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged ≥ 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till the program discontinued. The dose could be down-titrated during 4 weeks Interval at the discretion of Investigator. | 2 | 6 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
Source ClinicalTrials.gov
Trial
- Title
- A Study of Levetiracetam as Monotherapy or Adjunctive Treatment of Partial Seizures in Pediatric Epileptic Subjects Ranging From 1 Month to Less Than 4 Years of Age
- NCT number
- NCT03340064
- Phases
- PHASE3
- Conditions
- Partial Seizures
- Interventions
- Levetiracetam
- Lead sponsor
- UCB Japan Co. Ltd.
- Results first posted
- 2024-07-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03340064?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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GET https://conductscience.org/api/comparisons/v1/NCT03340064-sae