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

From: 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

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)
  1. 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.
  2. aPercentages are based on the number of subjects who received each dose at any point during the crossover phase.
  3. AE = adverse event; LDX = lisdexamfetamine dimesylate, TEAE = treatment-emergent adverse event.