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Table 4 TEAEs during the dose-optimization 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

Preferred Term, % (n)
Dose-Optimization Phase
(Safety Population)
  LDX-All Doses
(n = 142) a
Any TEAE 79.6 (113)
Anxiety 5.6 (8)
Decreased appetite 36.6 (52)
Dry mouth 30.3 (43)
Fatigue 4.9 (7)
Feeling jittery 5.6 (8)
Headache 19.7 (28)
Insomnia 18.3 (26)
Irritability 8.5 (12)
Nausea 7.7 (11)
Upper respiratory tract infection 9.9 (14)
  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 dose-optimization phase.
  3. AE = adverse event; LDX = lisdexamfetamine dimesylate, TEAE = treatment-emergent adverse event.