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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)