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Table 1 Summary of incidence of TEAEs and serious TEAEs

From: A retrospective medical chart review of clinical outcomes in children and adolescents with attention-deficit/hyperactivity disorder treated with guanfacine extended-release in routine Canadian clinical practice

Parameter Total (N = 330)
N of events N of patients % patients
Total TEAEs 349 147 44.5
Seriousness
  Non-serious 341 145 43.9
  Seriousa 8 7 2.1
Severity
  Mild 314 132 40.0
  Moderate 29 23 7.0
  Severe 6 5 1.5
Relationship to study drug
  Related 263 126 38.2
  Not related 86 55 16.7
Action taken
  No action taken 185 92 27.9
  Dose reduced 60 37 11.2
  Dose increased 50 33 10.0
  Dose interrupted 6 4 1.2
  Treatment discontinued 48 32 9.7
Outcome
  Resolved 299 133 40.3
  Resolved with sequelae 0 0 0.0
  Resolving 19 16 4.8
  Not resolved 22 18 5.5
  Death 0 0 0.0
  Unknown 9 9 2.7
  1. TEAE treatment-emergent adverse event
  2. aSerious TEAEs were hypotension (2 events), suicidal ideation (2 events), sinus bradycardia (1 event), aggression (1 event), agitation (1 event), and insomnia (1 event)