Comparison · NCT01146951-sae
Rufinamide (E2080) 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. Rufinamide (E2080) vs Placebo: serious adverse events. Trial comparisons, record NCT01146951-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01146951-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 | 0.0345 | 0.00611 | 0.172 | wilson | |
| Risk in group 2 | 0.0333 | 0.00591 | 0.167 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00115 | -0.135 | 0.141 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.03 | 0.0678 | 15.8 | log | |
| Odds ratio, group 1 over group 2 | 1.04 | 0.0617 | 17.4 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Rufinamide (E2080) than on Placebo | 870 | 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 | Rufinamide (E2080) | Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) \>= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening) | 1 | 29 | EG000 |
| Group 2 | Placebo | Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks. | 1 | 30 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months
Source ClinicalTrials.gov
Trial
- Title
- A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304)
- NCT number
- NCT01146951
- Phases
- PHASE3
- Conditions
- Lennox-Gastaut Syndrome
- Interventions
- Rufinamide (E2080), Placebo
- Lead sponsor
- Eisai Limited
- Results first posted
- 2013-11-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01146951?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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