Table 4.

Reported adverse events

System organ class  Preferred term	Palovarotene 5 mg		Palovarotene 10 mg		Overalla
	Japanese (N = 10), n (%)	Non-Japanese (N = 8), n (%)	Japanese (N = 10), n (%)	Non-Japanese (N = 8), n (%)	Japanese (N = 10), n (%)	Non-Japanese (N = 8), n (%)	All (N = 18), n (%)
At least one adverse event	2 (20.0)	2 (25.0)	2 (20.0)	0 (0.0)	4 (40.0)	2 (25.0)	6 (33.3)
Gastrointestinal disorders	1 (10.0)	0 (0.0)	1 (10.0)	0 (0.0)	2 (20.0)	0 (0.0)	2 (11.1)
Diarrhea	1 (10.0)	0 (0.0)	0 (0.0)	0 (0.0)	1 (10.0)	0 (0.0)	1 (5.6)
Nausea	0 (0.0)	0 (0.0)	1 (10.0)	0 (0.0)	1 (10.0)	0 (0.0)	1 (5.6)
Infections and infestations	0 (0.0)	1 (12.5)	0 (0.0)	0 (0.0)	0 (0.0)	1 (12.5)	1 (5.6)
Cellulitis	0 (0.0)	1 (12.5)	0 (0.0)	0 (0.0)	0 (0.0)	1 (12.5)	1 (5.6)
Investigations	0 (0.0)	1 (12.5)	0 (0.0)	0 (0.0)	0 (0.0)	1 (12.5)	1 (5.6)
Lipase increased	0 (0.0)	1 (12.5)	0 (0.0)	0 (0.0)	0 (0.0)	1 (12.5)	1 (5.6)
Musculoskeletal and connective tissue disorders	1 (10.0)	0 (0.0)	0 (0.0)	0 (0.0)	1 (10.0)	0 (0.0)	1 (5.6)
Arthralgia	1 (10.0)	0 (0.0)	0 (0.0)	0 (0.0)	1 (10.0)	0 (0.0)	1 (5.6)
Nervous system disorders	0 (0.0)	1 (12.5)	2 (20.0)	0 (0.0)	2 (20.0)	1 (12.5)	3 (16.7)
Headache	0 (0.0)	1 (12.5)	1 (10.0)	0 (0.0)	1 (10.0)	1 (12.5)	2 (11.1)
Migraine	0 (0.0)	0 (0.0)	1 (10.0)	0 (0.0)	1 (10.0)	0 (0.0)	1 (5.6)

^aMultiple occurrences of the same system organ class or preferred term for a participant were counted only once for each system organ class or preferred term. N number of participants