Comparison · NCT00360412-sae
Perampanel (Perampanel 2 mg or 4 mg During Core Study) vs Perampanel (Placebo During Core Study): 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. Perampanel (Perampanel 2 mg or 4 mg During Core Study) vs Perampanel (Placebo During Core Study): serious adverse events. Trial comparisons, record NCT00360412-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00360412-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 | 0.0858 | 0.0668 | 0.11 | wilson | |
| Risk in group 2 | 0.0991 | 0.0714 | 0.136 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0133 | -0.0547 | 0.0232 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.866 | 0.576 | 1.3 | log | |
| Odds ratio, group 1 over group 2 | 0.854 | 0.544 | 1.34 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Perampanel (Perampanel 2 mg or 4 mg During Core Study) than on Perampanel (Placebo During Core Study) | 75.4 | 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 | Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study. | 57 | 664 | EG001 |
| Group 2 | Perampanel (Placebo During Core Study) | Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study. | 33 | 333 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.
Source ClinicalTrials.gov
Trial
- Title
- A Study of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations
- NCT number
- NCT00360412
- Phases
- PHASE3
- Conditions
- Parkinson's Disease
- Interventions
- E2007
- Lead sponsor
- Eisai Inc.
- Results first posted
- 2013-02-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00360412?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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