Table 3.

Frequency of most commonly reported adverse reactions associated with ganaxolone in the randomised, double-blind, placebo-controlled trial in patients with cyclin-dependent kinase-like 5 deficiency disorder [181] as reported in the US prescribing information [143]. The Table includes reactions reported for the ganaxolone arm with a frequency ≥ 4% over placebo

Adverse reaction	Placebo (n = 51) (%)	Ganaxolone (n = 50) (%)
Somnolence	20	38
Pyrexia	8	18
Upper respiratory tract infection	6	10
Seasonal allergy	0	6
Salivary hypersecretion	2	6
Bronchitis	0	4