Table 4

Most frequent treatment-emergent AE and AE leading to discontinuation

Number (%) of subjects with AEPlacebo (n=188)SXB4.5g (n=194)SXB6g (n=189)Total (N=571)
Most frequent AE (≥5% and twice the placebo rate)
Any AE126 (67.0)146 (75.3)156 (82.5)428 (75.0)
Nausea16 (8.5)37 (19.1)40 (21.2)93 (16.3)
Dizziness3 (1.6)23 (11.9)25 (13.2)51 (8.9)
Vomiting6 (3.2)10 (5.2)16 (8.5)32 (5.6)
Insomnia6 (3.2)15 (7.7)8 (4.2)29 (5.1)
Anxiety3 (1.6)10 (5.2)15 (7.9)28 (4.9)
Somnolence3 (1.6)7 (3.6)11 (5.8)21 (3.7)
Fatigue4 (2.1)6 (3.1)11 (5.8)21(3.7)
Muscle spasms2 (1.1)8 (4.1)10 (5.3)20 (3.5)
Oedema peripheral4 (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 discontinuation10 (5.3)29 (14.9)39 (20.6)78 (13.7)
Nausea1 (0.5)6 (3.1)10 (5.3)17 (3.0)
Headache04 (2.1)8 (4.2)12 (2.1)
Vomiting1 (0.5)3 (1.5)6 (3.2)10 (1.8)
Anxiety1 (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.