Table 3.

Overall and specific treatment‐emergent adverse events (TEAEs) seen in at least two patients in any treatment group

	Vehicle (n = 83)	Difamilast 0·3% (n = 83)	Difamilast 1% (n = 85)
Patients with any TEAE	28 (34)	27 (33)	29 (34)
Patients with serious TEAE	0 (0)	0 (0)	0 (0)
Patients with severe TEAE	0 (0)	1 (1)	0 (0)
Patients who discontinued owing to TEAEs	5 (6)	1 (1)	2 (2)
Deaths	0 (0)	0 (0)	0 (0)
Specific events in at least two patients in any treatment group
Infections and infestations
Folliculitis	0 (0)	2 (2)	2 (2)
Gastroenteritis	1 (1)	2 (2)	2 (2)
Impetigo	5 (6)	6 (7)	2 (2)
Influenza	2 (2)	0 (0)	1 (1)
Molluscum contagiosum	0 (0)	0 (0)	2 (2)
Nasopharyngitis	3 (4)	5 (6)	7 (8)
Upper respiratory tract infection	2 (2)	0 (0)	0 (0)
Injury, poisoning and procedural complications
Arthropod bite	0 (0)	2 (2)	3 (4)
Skin abrasion	1 (1)	0 (0)	3 (4)
Skin and subcutaneous tissue disorders
Dermatitis atopic	4 (5)	2 (2)	3 (4)

TEAEs were coded to preferred terms according to the Medical Dictionary for Regulatory Activities (MedDRA) version 22.1. Data are n (%).