Table 3.
Summary of TEAEs by treatment period for Asian subgroup (over 12 months; Safety Analysis Set).
| Period 1 | PBO (n = 59) | LEM5 (n = 61) | LEM10 (n = 58) |
|---|---|---|---|
| Category, n (%) | |||
| Any TEAE | 29 (49.2) | 17 (27.9) | 27 (46.6) |
| Any treatment-related TEAE | 1 (1.7) | 7 (11.5) | 8 (13.8) |
| Any severe TEAE | 0 | 1 (1.6) | 0 |
| Any serious TEAE | 0 | 1 (1.6) | 0 |
| TEAE leading to study drug withdrawal | 0 | 2 (3.3) | 2 (3.4) |
| TEAEs with incidence >3% in any active treatment group, n (%) | |||
| Nasopharyngitis | 12 (20.3) | 7 (11.5) | 11 (19.0) |
| Somnolence | 0 | 6 (9.8) | 6 (10.3) |
| Headache | 1 (1.7) | 2 (3.3) | 1 (1.7) |
| Ligament sprain | 1 (1.7) | 0 | 2 (3.4) |
| Sleep paralysis |
0 |
0 |
2 (3.4) |
| Period 2 |
LEM5a (n = 51) |
LEM10a (n = 49) |
|
| Category, n (%) | |||
| Any TEAE | 15 (29.4) | 19 (38.8) | |
| Any treatment-related TEAE | 3 (5.9) | 4 (8.2) | |
| Any severe TEAE | 1 (2.0) | 0 | |
| Any serious TEAE | 1 (2.0) | 0 | |
| TEAE leading to study drug withdrawal | 0 | 0 | |
| TEAEs with incidence >3% in any active treatment group, n (%) | |||
| Nasopharyngitis | 2 (3.9) | 3 (6.1) | |
| Somnolence | 0 | 3 (6.1) | |
| Influenza | 1 (2.0) | 3 (6.1) | |
| Sleep paralysis | 2 (3.9) | 2 (4.1) | |
| Headache | 1 (2.0) | 2 (4.1) | |
| Cystitis |
0 |
2 (4.1) |
|
| Full study period (combined Period 1 and Period 2) |
LEM5 (n = 61) |
LEM10 (n = 58) |
|
| Category, n (%) | |||
| Any TEAE | 27 (44.3) | 33 (56.9) | |
| Any treatment-related TEAE | 9 (14.8) | 12 (20.7) | |
| Any severe TEAE | 2 (3.3) | 0 | |
| Any serious TEAE | 2 (3.3) | 0 | |
| TEAE leading to study drug withdrawal | 2 (3.3) | 2 (3.4) | |
| TEAEs with incidence >4% in any active treatment group, n (%) | |||
| Nasopharyngitis | 8 (13.1) | 14 (24.1) | |
| Somnolence | 6 (9.8) | 9 (15.5) | |
| Influenza | 2 (3.3) | 4 (6.9) | |
| Headache | 3 (4.9) | 2 (3.4) | |
Treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) with onset date on or after the first dose of study drug up to 14 days after the last dose of study drug. Within each treatment period, subjects with ≥2 AEs with the same preferred term were counted only once for that preferred term.
LEM5, lemborexant 5 mg; LEM10, lemborexant 10 mg; PBO, placebo.
a
Only those subjects who had received LEM in both Periods 1 and 2 at the indicated dose were included in this analysis.