Number (%) of subjects with AE | Placebo (n=188) | SXB4.5g (n=194) | SXB6g (n=189) | Total (N=571) |
---|---|---|---|---|
Most frequent AE (≥5% and twice the placebo rate) | ||||
Any AE | 126 (67.0) | 146 (75.3) | 156 (82.5) | 428 (75.0) |
Nausea | 16 (8.5) | 37 (19.1) | 40 (21.2) | 93 (16.3) |
Dizziness | 3 (1.6) | 23 (11.9) | 25 (13.2) | 51 (8.9) |
Vomiting | 6 (3.2) | 10 (5.2) | 16 (8.5) | 32 (5.6) |
Insomnia | 6 (3.2) | 15 (7.7) | 8 (4.2) | 29 (5.1) |
Anxiety | 3 (1.6) | 10 (5.2) | 15 (7.9) | 28 (4.9) |
Somnolence | 3 (1.6) | 7 (3.6) | 11 (5.8) | 21 (3.7) |
Fatigue | 4 (2.1) | 6 (3.1) | 11 (5.8) | 21(3.7) |
Muscle spasms | 2 (1.1) | 8 (4.1) | 10 (5.3) | 20 (3.5) |
Oedema peripheral | 4 (2.1) | 3 (1.5) | 12 (6.3) | 19 (3.3) |
Most frequent AE leading to discontinuation (≥3% and twice the placebo rate) | ||||
Any AE leading to discontinuation | 10 (5.3) | 29 (14.9) | 39 (20.6) | 78 (13.7) |
Nausea | 1 (0.5) | 6 (3.1) | 10 (5.3) | 17 (3.0) |
Headache | 0 | 4 (2.1) | 8 (4.2) | 12 (2.1) |
Vomiting | 1 (0.5) | 3 (1.5) | 6 (3.2) | 10 (1.8) |
Anxiety | 1 (0.5) | 1 (0.5) | 6 (3.2) | 8 (1.4) |
AE, adverse event; SXB4.5g, sodium oxybate 4.5 g/night; SXB6g, sodium oxybate 6 g/night.