Table 1.
Baseline patient demographics and clinical characteristics for safety analysis set
| Characteristic | OSA (n = 468) | SWD (n = 108) | Narcolepsy (n = 155) | Total (N = 731) |
|---|---|---|---|---|
| Age, year | ||||
| Mean (SD) | 50.2 (8.80) | 42.7 (9.89) | 38.9 (12.55) | 46.7 (10.97) |
| Rangea | 25–69 | 19–63 | 18–67 | 18–69 |
| Sex, n (%) | ||||
| Men | 343 (73) | 61 (56) | 70 (45) | 474 (65) |
| Women | 125 (27) | 47 (44) | 85 (55) | 257 (35) |
| Race, n (%) | ||||
| White | 404 (86) | 80 (74) | 115 (74) | 599 (82) |
| Black | 31 (7) | 21 (19) | 22 (14) | 74 (10) |
| Asian | 4 (< 1) | 1 (< 1) | 2 (1) | 7 (< 1) |
| Other | 28 (6) | 6 (6) | 10 (6) | 44 (6) |
| Missing | 1 (< 1) | 0 | 6 (4) | 7 (< 1) |
| BMI, kg/m2, mean (SD) | 36.9 (8.00) | 29.3 (6.97) | 29.1 (6.47) | 34.1 (8.40) |
| Use of concomitant therapy, n (%) | 456 (97) | 90 (83) | 135 (87) | 681 (93) |
| CPAP use, h/d, mean (SD) | 6.9 (1.05) | — | — | — |
| CGI-S, n (%) | ||||
| Moderately ill | 252 (54) | 55 (51) | 51 (33) | 358 (49) |
| Markedly ill | 144 (31) | 40 (37) | 75 (48) | 259 (35) |
| Severely ill | 64 (14) | 11 (10) | 27 (17) | 102 (14) |
| Extremely ill | 8 (2) | 2 (2) | 2 (1) | 12 (2) |
| ESS, mean (SD)b | 15.8 (3.52) | — | 16.9 (4.12) | — |
| BFI, mean (SD)c | ||||
| Global | 4.9 (1.85) | 5.1 (1.71) | 5.7 (1.98) | — |
| Worst | 7.2 (2.02) | 7.8 (2.01) | 7.8 (2.25) | — |
BFI refers to Brief Fatigue Inventory; BMI, body mass index; CGI-S, Clinical Global Impression of Severity of Illness; CPAP, continuous positive airway pressure; ESS, Epworth Sleepiness Scale; OSA, obstructive sleep apnea; SWD, shift work disorder.
a
Five patients over the age of 65 were granted a protocol exception and were enrolled in the study.
b
Baseline ESS scores were reported for 454 patients with treated OSA and 147 patients with narcolepsy.
c
Baseline BFI scores were reported for 459 patients with treated OSA, 106 patients with SWD, and 150 patients with narcolepsy.