TABLE 4.
Summary and subgroup comparisons of TEAEs
| Subgroup | TEAEs, n (%) | Serious TEAEs, n (%) | Drug‐related TEAEs, n (%) a |
|---|---|---|---|
| Age group | |||
| 6–11 years, n = 45 | 41 (91.1) | 18 (40.0) | 3 (6.7) |
| ≥12 years, n = 118 | 93 (78.8) | 32 (27.1) | 27 (22.9) |
| Concomitant benzodiazepine use | |||
| Yes, n = 125 | 107 (85.6) | 42 (33.6) | 26 (20.8) |
| No, n = 38 | 27 (71.1) | 8 (21.1) | 4 (10.5) |
| Seasonal allergies/rhinitis | |||
| Yes, n = 70 | 60 (85.7) | 26 (37.1) | 15 (21.4) |
| No, n = 93 | 74 (79.6) | 24 (25.8) | 15 (16.1) |
| Monthly dosing frequency, mean | |||
| 1–2, n = 87 | 68 (78.2) | 26 (29.9) | 10 (11.5) |
| >2–5, n = 68 | 58 (85.3) | 21 (30.9) | 17 (25.0) |
| >5, n = 8 | 8 (100.0) | 3 (37.5) | 3 (37.5) |
Abbreviation: TEAE, treatment‐emergent adverse event.
a
Possibly or probably related to treatment.