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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.