Comparison · NCT01405053-sae
Rufinamide vs Any Other Approved Antiepileptic Drug: 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. Rufinamide vs Any Other Approved Antiepileptic Drug: serious adverse events. Trial comparisons, record NCT01405053-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01405053-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 | 0.4 | 0.234 | 0.593 | wilson | |
| Risk in group 2 | 0.417 | 0.193 | 0.68 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0167 | -0.328 | 0.278 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.96 | 0.421 | 2.19 | log | |
| Odds ratio, group 1 over group 2 | 0.933 | 0.23 | 3.78 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Rufinamide than on Any Other Approved Antiepileptic Drug | 60 | 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 | Rufinamide | Participants received rufinamide oral suspension as an add-on therapy to the participant's existing regimen of 1 to 3 AEDs. Participants underwent a 2 week Titration Period during which rufinamide dose was increased from 10 mg/kg/day in increments of 10 mg/kg/day every 3 days to 40 mg/kg/day and thereafter in increments of 5 mg/kg/day to the target maintenance dose of 45 mg/kg/day (all daily treatments were to be administered in 2 equally divided doses). Rufinamide dose reached at the end of the Titration period were to be maintained the same throughout the 104-week Maintenance Period. At the end of Maintenance Period, rufinamide dose should be tapered (as needed) over a period of 2 weeks. | 10 | 25 | EG000 |
| Group 2 | Any Other Approved Antiepileptic Drug | Participants received any other approved AEDs of the investigator's choice, dosed according to the investigator's usual practice, added to the participant's existing regimen of 1 to 3 AEDs. At the end of Maintenance Period, the AED comparator would be discontinued according to the investigator's usual practice. | 5 | 12 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From Visit 1 up to 30 days after the last study visit, or until resolution, whichever came first (up to approximately Week 106)
Source ClinicalTrials.gov
Trial
- Title
- Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs
- NCT number
- NCT01405053
- Phases
- PHASE3
- Conditions
- Lennox-Gastaut Syndrome
- Interventions
- Rufinamide, Any other approved Antiepileptic Drug
- Lead sponsor
- Eisai Inc.
- Results first posted
- 2019-08-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01405053?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
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GET https://conductscience.org/api/comparisons/v1/NCT01405053-sae