Comparison · NCT00334958-sae
Rufinamide 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
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ConductScience Library. Rufinamide vs Placebo: serious adverse events. Trial comparisons, record NCT00334958-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00334958-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 | 0.0341 | 0.0157 | 0.0724 | wilson | |
| Risk in group 2 | 0.0389 | 0.019 | 0.0781 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0048 | -0.0481 | 0.0384 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.877 | 0.301 | 2.56 | log | |
| Odds ratio, group 1 over group 2 | 0.872 | 0.287 | 2.65 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Rufinamide than on Placebo | 208 | 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 | For the 12-day Titration Phase, rufinamide were administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the 12 week Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Participants unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group). | 6 | 176 | EG000 |
| Group 2 | Placebo | For 12-day Titration Phase and 12 week Maintenance Phase, placebo tablets matching to rufinamide 400 mg oral tablets were administered according to the same regimen scheme as described for rufinamide. For 12-day Titration Phase, 1 matching placebo tablet were administered twice daily and increased by 1 tablet every 3 days up to maximum of 4 matching placebo tablets twice daily (placebo tablet matched to rufinamide total daily dose of 3200 mg). For the 12 week maintenance phase, 4 placebo tablets matching to rufinamide maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Similar to the dose reduction permitted in the rufinamide group, participants in placebo group were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily. | 7 | 180 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Source ClinicalTrials.gov
Trial
- Title
- Rufinamide Given as Adjunctive Therapy in Participants With Refractory Partial Seizures
- NCT number
- NCT00334958
- Phases
- PHASE3
- Conditions
- Epilepsy
- Interventions
- Placebo, Rufinamide
- Lead sponsor
- Eisai Inc.
- Results first posted
- 2013-02-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00334958?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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