TABLE 4.
TEAE (safety analysis seta) in female participants 40-58 years of age
| Treatment Period 1 (1st 6 mo) | Treatment Period 2 (2nd 6 mo) | ||||
|---|---|---|---|---|---|
| Placebo (n = 90) |
LEM5 (n = 82) |
LEM10 (n = 107) |
LEM5-LEM5 (n = 64) |
LEM10-LEM10 (n = 76) |
|
| TEAEb | 58 (64.4) | 53 (64.6) | 63 (58.9) | 37 (57.8) | 34 (44.7) |
| Treatment-related | 14 (15.6) | 22 (26.8) | 33 (30.8) | 8 (12.5) | 5 (6.6) |
| Severe | 4 (4.4) | 1 (1.2) | 2 (1.9) | 2 (3.1) | 1 (1.3) |
| Serious | 2 (2.2) | 1 (1.2) | 3 (2.8) | 1 (1.6) | 1 (1.3) |
| Leading to study drug withdrawal | 5 (5.6) | 3 (3.7) | 9 (8.4) | 3 (4.7) | 1 (1.3) |
| Leading to interruption of study drug | 5 (5.6) | 4 (4.9) | 2 (1.9) | 3 (4.7) | 0 |
| Death | 0 | 0 | 0 | 0 | 0 |
| TEAE reported in >5% of participants in any treatment group | |||||
| Somnolence | 1 (1.1) | 8 (9.8) | 13 (12.1) | 1 (1.6) | 1 (1.3) |
| Nasopharyngitis | 13 (14.4) | 8 (9.8) | 10 (9.3) | 9 (14.1) | 7 (9.2) |
| Headache | 10 (11.1) | 11 (13.4) | 8 (7.5) | 4 (6.3) | 4 (5.3) |
| Influenza | 5 (5.6) | 4 (4.9) | 6 (5.6) | 0 | 1 (1.3) |
| Upper respiratory tract infection | 2 (2.2) | 5 (6.1) | 4 (3.7) | 4 (6.3) | 2 (2.6) |
All data are presented as n (%).
LEM5, lemborexant 5 mg; LEM10, lemborexant 10 mg; TEAE, treatment-emergent adverse event.
aSafety analysis set was defined as all randomized participants who received at least one dose of study drug and had at least one postdose safety assessment.
bA TEAE was defined as an adverse event 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, participants with at least two adverse events with the same preferred term are counted only once for that preferred term.