Table 2 Types of psychiatric adverse events

Number of psychiatric AEs % (n)

100% (374)

55.9% (209)

44.1% (165)

Aggressivness/agitation/challenging behaviors % (n) *

22.7% (85)

15.3% (32)

32% (53)

Agressivness/impulsivity/anger

14.7% (55)

9% (19)

21.8% (36)

Behavior disorder

1.6% (6)

0.5% (1)

3% (5)

Motor restlessness

6.4% (24)

5.7% (12)

7.3% (12)

Mood changes % (n) *

18.4% (69)

23.9% (50)

11.5% (19)

Elevated mood

7.5% (28)

12% (25)

1.8% (3)

Sad or depressed mood

6.4% (24)

9% (19)

3% (5)

Emotional lability

4.5% (17)

2.8% (6)

6.7% (11)

Suicidal ideation/behavior % (n)

11.8% (44)

12.4% (26)

10.9% (18)

Apathy/restricted range of emotion/lack of interest % (n) *

10.9% (41)

15.3% (32)

5.4% (9)

Irritability % (n)

6.4% (24)

5.7% (12)

7.3% (12)

Trouble paying attention/concentrating % (n)

7.8% (29)

9.6% (20)

5.5% (9)

Anxiety % (n)

5.6% (21)

3.8% (8)

7.9% (13)

Hallucinations % (n)

3.7% (14)

2.4% (5)

5.5% (9)

Racing thoughts % (n)

2.9% (11)

1.9% (4)

4.2% (7)

Sexual dysfonction % (n)

2.4% (9)

3.8% (8)

0.6% (1)

Psychiatric relapse % (n)

2.4% (9)

1.9% (4)

3% (5)

Others (enuresis, encopresis, addiction, scaring, swinging, etc.) % (n)

4.8% (18)

3.8% (8)

6% (10)