Table 3 Per-protocol analysis of outcomes between study groups*
Outcomes | Study group (n = 59) | Comparison group (n = 57) | Risk Ratio (95%CI) | p-value |
|---|---|---|---|---|
Improved seizures (≥ 50% SFR) | 22 (37.3%) | 7 (12.3%) | 3.0 (1.4–6.6) | 0.002 |
Status epilepticus | 1 (1.7%) | 8 (14.0%) | 0.12 (0.02–0.94) | 0.016 |
Escalation of ASMs | 2 (3.4%) | 11 (19.3%) | 0.18 (0.04–0.76) | 0.008 |
Nausea | 7 (11.9%) | 6 (10.5%) | 1.1 (0.40–3.2) | 0.819 |
Vomiting | 5 (8.5%) | 2 (3.5%) | 2.4 (0.49-12) | 0.439 |
Diarrhea | 6 (10.2%) | 3 (5.3%) | 1.9 (0.51–7.4) | 0.491 |
Skin rash | 3 (5.1%) | 1 (1.8%) | 2.9 (0.31-27) | 0.619 |