Skip to main content

Table 6 TEAEs by sex in the dose-optimization phase while receiving LDX with an incidence of ≥10% in the dose-optimization and/or crossover phase

From: Efficacy and tolerability of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder: sex and age effects and effect size across the day

AE-Preferred Term Dose-Optimization Phase
  Males Females
  (n = 98) (n = 31)
  n (%) n (%)
Any AE 83 (84.7) 27 (87.1)
Abdominal pain upper 16 (16.3) 4 (12.9)
Affect lability 11 (11.2) 2 (6.5)
Decreased appetite 47 (48.0) 14 (45.2)
Headache 18 (18.4) 4 (12.9)
Insomnia 30 (30.6) 5 (16.1)
Irritability 16 (16.3) 5 (16.1)
Nausea 7 (7.1) 4 (12.9)
  1. For tables 6-9: 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.