TABLE 2.
Overview of TEAEs and most common TEAEs occurring in ≥4% of Indian patients in the total perampanel group during the double‐blind or OLEx studies (Safety Analysis Set)
| Double‐blind studies | OLEx studies | ||||||
|---|---|---|---|---|---|---|---|
| Placebo (n = 39) | Perampanel | Perampanel (n = 110) | |||||
| 2 mg/day (n = 12) | 4 mg/day (n = 9) | 8 mg/day (n = 54) | 12 mg/day (n = 14) | Total (n = 89) | |||
| TEAEs, n (%) | 21 (53.8) | 7 (58.3) | 2 (22.2) | 35 (64.8) | 8 (57.1) | 52 (58.4) | 92 (83.6) |
| Treatment‐related TEAEs, n (%) | 15 (38.5) | 3 (25.0) | 1 (11.1) | 25 (46.3) | 6 (42.9) | 35 (39.3) | 65 (59.1) |
| Serious TEAEs, n (%) | 1 (2.6) | 2 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (2.2) | 9 (8.2) |
| TEAEs leading to study‐drug withdrawal, n (%) | 0 (0.0) | 1 (8.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.1) | 8 (7.3) |
| Most common (≥4%) TEAEs, n (%) | |||||||
| Dizziness | 2 (5.1) | 0 (0.0) | 0 (0.0) | 7 (13.0) | 3 (21.4) | 10 (11.2) | 23 (20.9) |
| Pyrexia | 2 (5.1) | 3 (25.0) | 0 (0.0) | 5 (9.3) | 0 (0.0) | 8 (9.0) | 24 (21.8) |
| Headache | 3 (7.7) | 2 (16.7) | 0 (0.0) | 5 (9.3) | 1 (7.1) | 8 (9.0) | 15 (13.6) |
| Somnolence | 0 (0.0) | 1 (8.3) | 0 (0.0) | 5 (9.3) | 0 (0.0) | 6 (6.7) | 16 (14.5) |
| Eosinophilia | 3 (7.7) | 0 (0.0) | 0 (0.0) | 4 (7.4) | 0 (0.0) | 4 (4.5) | 17 (15.5) |
| Weight increased | 1 (2.6) | 0 (0.0) | 0 (0.0) | 3 (5.6) | 1 (7.1) | 4 (4.5) | 11 (10.0) |
| Convulsion | 3 (7.7) | 0 (0.0) | 0 (0.0) | 1 (1.9) | 0 (0.0) | 1 (1.1) | 11 (10.0) |
| Decreased appetite | 1 (2.6) | 0 (0.0) | 0 (0.0) | 1 (1.9) | 2 (14.3) | 3 (3.4) | 7 (6.4) |
| Upper respiratory tract infection | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (3.7) | 0 (0.0) | 2 (2.2) | 10 (9.1) |
| Aggression | 1 (2.6) | 0 (0.0) | 0 (0.0) | 3 (5.6) | 0 (0.0) | 3 (3.4) | 5 (4.5) |
| Ataxia | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.9) | 0 (0.0) | 1 (1.1) | 10 (9.1) |
| Nasopharyngitis | 0 (0.0) | 1 (8.3) | 0 (0.0) | 1 (1.9) | 0 (0.0) | 2 (2.2) | 8 (7.3) |
| Nausea | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (14.3) | 2 (2.2) | 6 (5.5) |
| Vomiting | 1 (2.6) | 0 (0.0) | 0 (0.0) | 2 (3.7) | 0 (0.0) | 2 (2.2) | 5 (4.5) |
| Gamma‐glutamyltransferase increased | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (7.1) | 1 (1.1) | 6 (5.5) |
| Balance disorder | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (7.1) | 1 (1.1) | 5 (4.5) |
| Fall | 1 (2.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 6 (5.5) |
| Head injury | 1 (2.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 5 (4.5) |
| Vertigo | 1 (2.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 5 (4.5) |
Abbreviations: AE, adverse event; OLEx, open‐label extension; TEAE, treatment‐emergent adverse event.
A TEAE is defined as an AE with an onset date, or a worsening in severity from baseline, on or after the first dose of study drug up to 30 days following study‐ drug discontinuation. A patient with ≥2 AEs in the same system organ class or with the same preferred term is counted only once for that system organ class or preferred term.