Journal of the Korean Academy of Child and Adolescent Psychiatry : eISSN 2233-9183 / pISSN 1225-729X

Table. 3.

Table. 3.

Treatment-emergent adverse events that occurred in ≥ 5% of subjects

  MedDRA preferred term Incidence, n (%)
Nausea/vomiting 23 (35.4)
Decreased appetite 21 (32.3)
Trouble falling asleep 18 (27.7)
Headache 11 (16.9)
Somnolence 8 (12.3)
Stomach discomfort 7 (10.8)
Sleep maintenance insomnia 7 (10.8)
Fatigue 7 (10.8)
Depressed mood 6 (9.2)
Irritability 5 (7.7)
Anger/hostility 5 (7.7)
Labile affect 5 (7.7)
Increased appetite 5 (7.7)
Anxiety 5 (7.7)
Dizziness 5 (7.7)
Abdominal pain 4 (6.2)
Nervousness 4 (6.2)

MedDRA: Medical dictionary for regulatory activities

J Korean Acad Child Adolesc Psychiatry 2019;30:74-82 https://doi.org/10.5765/jkacap.180030
© 2019 J Korean Acad Child Adolesc Psychiatry