Analysis of Falls in Epilepsy Patients with Partial Onset Seizures in Perampanel Phase 3 Trials (P3.272)
Bibliographic record
Abstract
OBJECTIVE: Conduct a post-hoc analysis of falls among patients in Phase 3 clinical trials of perampanel, an orally active, noncompetitive, selective AMPA-receptor-antagonist approved (EU, US, Canada) as adjunctive therapy for partial-onset seizures (POS). BACKGROUND: Incidence of injuries/related hospitalizations is greater in patients with epilepsy than the general population. Falls are a common cause of injury among epilepsy patients. DESIGN/METHODS: Patients (蠅12y, receiving 1-3 AEDs) with uncontrolled POS randomized to once-daily placebo or perampanel (2, 4, 8, or 12 mg) in the Phase 3 double-blind trials. Four-period design: 6-wk baseline, 6-wk titration, 13-wk maintenance, 4-wk follow-up for patients not entering open-label extension. The adverse event (AE) of falls was analyzed. RESULTS: Safety population: 1480 patients (placebo: n=442; perampanel: n=1038 [2mg,n=180; 4mg,n=172; 8mg,n=431; 12mg,n=255]). Overall, 5.1% (53/1038) patients treated with perampanel and 3.4% (15/442) receiving placebo experienced falls. Compared to patients who did not have falls (n=1402), patients with falls including those occurring during pre-randomization phase (n=75) had a longer mean duration since diagnosis of epilepsy (25.6y vs 21.1y) and were older (39.8y vs 34.6y). The exposure-adjusted rate for falls (falls/patient-months of exposure) during the double-blind trials was greater for perampanel than for placebo (0.0173 vs 0.0093 falls/patient-months) and was dose dependent. Although overall rate of falls was notably higher among subjects with concurrent seizures than those without, the incremental rate for subjects on perampanel above the rate for those on placebo was nearly identical for those with concurrent seizures (0.0113 for perampanel vs 0.0071 for placebo falls/patient-months) and without concurrent seizures (0.0058 for perampanel vs 0.0016 for placebo falls/patient-months). CONCLUSIONS: The data suggest that falls are related to perampanel exposure whether concurrent or non-concurrent with seizures. Falls are more common in subjects having concurrent seizures, as expected, and in older patients. Study Supported by: Eisai Inc.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.009 | 0.006 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.006 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.005 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".