A 13-hour laboratory school study of lisdexamfetamine dimesylate in school-aged children with attention-deficit/hyperactivity disorder

Table 4 TEAEs ≥ 10% During Dose-Optimization and Crossover Phases

Adverse Event Preferred Term	Dose-Optimization Phase (Safety Population)	Crossover Phase (Randomized Population)
	LDX All Doses (N = 129) n (%)	LDX All Doses (n = 115) n (%)	Placebo (n = 115) n (%)
Any adverse event	110 (85.3)	38 (33.0)	22 (19.1)
Affect lability	13 (10.1)	0 (0.0)	1 (0.9)
Decreased appetite	61 (47.3)	7 (6.1)	1 (0.9)
Headache	22 (17.1)	6 (5.2)	2 (1.7)
Insomnia	35 (27.1)	5 (4.3)	0 (0.0)
Irritability	21 (16.3)	1 (0.9)	1 (0.9)
Upper abdominal pain	20 (15.5)	2 (1.7)	3 (2.6)

TEAEs were assigned to either the open-label dose-optimization phase or the double-blind crossover phase of the study and were summarized separately. TEAEs that continued uninterrupted from the dose-optimization to the crossover phase without a change in severity were counted only in the dose-optimization phase category. TEAEs with a change in severity across phases or that resolved and then restarted in the crossover phase were counted both in the dose-optimization and crossover arms. TEAEs for which a missing or incomplete start date made it impossible to determine in which phase of the study they started were counted as starting in the dose-optimization phase.
LDX: lisdexamfetamine dimesylate; TEAEs: treatment-emergent adverse events

ISSN: 1753-2000