Table 2.
TEAEs reported in ≥5% of participants receiving SXB in either study.
| TEAEs | SXB-15, n (%) | SXB-22, n (%) | ||
|---|---|---|---|---|
| Placebo (n = 60) | All SXB (n = 186) | Placebo (n = 56) | All SXB (n = 112) | |
| Headache | 7 (11.7) | 35 (18.8) | 12 (21.4) | 16 (14.3) |
| Dizziness | 1 (1.7) | 31 (16.7) | 3 (5.4) | 16 (14.3) |
| Nausea | 2 (3.3) | 34 (18.3) | 1 (1.8) | 24 (21.4) |
| Enuresis | 1 (1.7) | 16 (8.6) | 0 | 3 (2.7) |
| Nasopharyngitis | 6 (10.0) | 13 (7.0) | 4 (7.1) | 7 (6.3) |
| Diarrhea | 1 (1.7) | 10 (5.4) | 0 | 5 (4.5) |
| Vomiting | 1 (1.7) | 10 (5.4) | 0 | 12 (10.7) |
| Somnolence | 0 | 8 (4.3) | 4 (7.1) | 7 (6.3) |
Adverse events experienced after the start of the double-blind treatment in the all-treated population. SXB = sodium oxybate; TEAE = treatment-emergent adverse event.