Table 2.

Adverse events.

Variable		Fezakinumab	Placebo	P- value$
		N=40	N=20
No. of adverse events		18	10
Severity	Mild	9	6
	Moderate	8	3
	Severe	1	0
Mean no. of adverse events per patient		0·45	0·5	0·82
Any adverse event—no. of patients (%)		14 (35%)	8 (40%)	0·78
Serious adverse event * — no. of patients (%)		2 (5%)**	0	0·55
Study discontinuation due to adverse event—no. of patients (%)		2 (5%)	0	0·55
Common adverse events: ‡
Upper respiratory infection, viral— no. of patients (%)		4 (10%)	0	0·29

^*A serious adverse event was defined as an event that was fatal or life threatening, required or prolonged hospitalization, or caused persistent or substantial disability or incapacity or a congenital anomaly or birth defect or an event that was considered by the investigator to be a medically important event.

^**Facial cellulitis after a dental procedure; pregnancy with elective termination.

^‡Common adverse events were those that occurred in >5% in any treatment group.

^$The differences of the proportions were tested using a Fisher’s exact test.