Table 6.

Safety Profile of Cariprazine in Pediatric Patients with Autism Spectrum Disorder

Parameter	Cohort 1 (10–12 years), N = 3	Cohort 1 (13–17 years), N = 4	Cohort 2 (10–12 years), N = 3	Cohort 2 (13–17 years), N = 3	Cohort 3 (5–9 years), N = 6	Cohort 4 (5–9 years), N = 6
≥1 TEAE, n (%)	1 (33.3)	3 (75.0)	2 (66.7)	2 (66.7)	4 (66.7)	2 (33.3)
TEAEs occurring in ≥2 patients
ALT increased	1 (33.3)				1 (16.7)
Increased appetite					2 (33.3)
Dizziness	1 (33.3)	1 (25.0)
Agitation		2 (50.0)
Nasal congestion	1 (33.3)			1 (33.3)
Weight increased	1 (33.3)		2 (66.7)		4 (66.7)	1 (16.7)
Potentially clinically significant weight increase
Weight increase ≥7%,a n (%)	1 (33.3)	1 (25.0)	2 (66.7)		6 (100.0)	1 (25.0)
Change from baseline,a mean (SD), kg	2.86 (2.394)		4.03 (3.331)		4.38 (1.489)	0.15 (1.991)

^a From baseline to end of study.

TEAE, treatment-emergent adverse event; SD, standard deviation.