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

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

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)
  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. LDX: lisdexamfetamine dimesylate; TEAEs: treatment-emergent adverse events