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Table 5 TEAEs Leading to Discontinuation by System Organ Class and Preferred Term (All Occurrences: Safety Population, N = 129)

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

System Organ Class Preferred Term n (%)
Gastrointestinal   4 (3.1)
  Abdominal pain 2 (1.6)
  Diarrhea 1 (0.8)
  Nausea 2 (1.6)
  Vomiting 2 (1.6)
General   4 (3.1)
  Fatigue 2 (1.6)
  Irritability 2 (1.6)
Investigations   1 (0.8)
  Weight decrease 1 (0.8)
Metabolic/nutritional   3 (2.3)
  Anorexia 2 (1.6)
  Decreased appetite 1 (0.8)
Nervous system   2 (1.6)
  Amnesia 1 (0.8)
  Psychomotor hyperactivity 2 (1.6)
  Tardive dyskinesia
(lip-smacking)
1 (0.8)
Psychiatric   5 (3.9)
  Insomnia/sleep disorder 4 (3.1)
  Suicidal ideation 1 (0.8)
  Tearfulness 1 (0.8)
  1. TEAEs: treatment-emergent adverse events