Randomized, double-blind, placebo-controlled, crossover study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder: novel findings using a simulated adult workplace environment design

Table 5 TEAEs during the crossover phase for all TEAEs with incidence ≥ 5% in either the dose-optimization and/or the crossover phases

AE Preferred Term, % (n)	Crossover Phase (Randomized Population)
	LDX-All Doses (n = 115) ^a	Placebo (n = 117) ^a
Any TEAE	27.8 (32)	35.9 (42)
Anxiety	1.7 (2)	0
Decreased appetite	3.5 (4)	1.7 (2)
Dry mouth	3.5 (4)	0.9 (1)
Fatigue	0.9 (1)	12.0 (14)
Feeling jittery	0	0
Headache	1.7 (2)	2.6 (3)
Insomnia	2.6 (3)	1.7 (2)
Irritability	0	0.9 (1)
Nausea	1.7 (2)	0
Upper respiratory tract infection	1.7 (2)	7.7 (9)

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.
^aPercentages are based on the number of subjects who received each dose at any point during the crossover phase.
AE = adverse event; LDX = lisdexamfetamine dimesylate, TEAE = treatment-emergent adverse event.

ISSN: 1744-9081