Table 2 Most frequent treatment-emergent AEs by dose at time of AE onset in safety population
AE | Sodium oxybate dose at event onseta | ||||
|---|---|---|---|---|---|
|  | 4.5 g (n = 545) | 6 g (n = 432) | 7.5 g (n = 239) | 9 g (n = 112) | Total (N = 560)b |
Any AE, number (%)c | 295 (54.1) | 265 (61.3) | 163 (68.2) | 88 (78.6) | 498 (88.9) |
  Nausea | 44 (8.1) | 44 (10.2) | 23 (9.6) | 10 (8.9) | 112 (20.0) |
  Headache | 42 (7.7) | 43 (10.0) | 21 (8.8) | 7 (6.3) | 106 (18.9) |
  Dizziness | 29 (5.3) | 28 (6.5) | 13 (5.4) | 6 (5.4) | 72 (12.9) |
  Nasopharyngitis | 25 (4.6) | 21 (4.9) | 7 (2.9) | 6 (5.4) | 57 (10.2) |
  Vomiting | 21 (3.9) | 16 (3.7) | 9 (3.8) | 7 (6.3) | 52 (9.3) |
  Sinusitis | 14 (2.6) | 21 (4.9) | 13 (5.4) | 4 (3.6) | 50 (8.9) |
  Diarrhea | 16 (2.9) | 24 (5.6) | 7 (2.9) | 4 (3.6) | 49 (8.8) |
  Anxiety | 18 (3.3) | 18 (4.2) | 11 (4.6) | 3 (2.7) | 44 (7.9) |
  Insomnia | 12 (2.2) | 14 (3.2) | 10 (4.2) | 3 (2.7) | 38 (6.8) |
  Influenza | 12 (2.2) | 14 (3.2) | 9 (3.8) | 3 (2.7) | 37 (6.6) |
  Somnolence | 10 (1.8) | 15 (3.5) | 4 (1.7) | 7 (6.3) | 34 (6.1) |
  Upper respiratory tract infection | 2 (0.4) | 18 (4.2) | 11 (4.6) | 4 (3.6) | 34 (6.1) |
  Muscle spasms | 7 (1.3) | 8 (1.9) | 10 (4.2) | 4 (3.6) | 29 (5.2) |
  Urinary tract infection | 5 (0.9) | 8 (1.9) | 5 (2.1) | 6 (5.4) | 22 (3.9) |
  Gastroenteritis viral | 1 (0.2) | 4 (0.9) | 5 (2.1) | 6 (5.4) | 16 (2.9) |