Table 2.

Overview of TEAEs [safety analysis set]

	All risankizumab [N = 65; PY = 167.0]
	Number of patients [%]	E/100 PY
Any AE	60 [92.3]	408.4
AE possibly related to study druga	26 [40.0]	49.7
Serious AE	23 [35.4]	24.6
Severe AEb	14 [21.5]	15.0
AE leading to discontinuation of study drug	6 [9.2]	4.2
All deaths	0	0
Infection	48 [73.8]	112.0
Serious infection	6 [9.2]	4.2
Opportunistic infection	3 [4.6]c	1.8
Fungal infection	7 [10.8]c	6.6
Tuberculosis	0	0
Herpes zoster	0	0
Malignancy excluding NMSC	0	0
Hypersensitivity	16 [24.6]	10.2
Anaphylactic reaction	1d [1.5]	0.6
Hepatic event	6 [9.2]	10.2
Adjudicated MACE	0	0

AE, adverse event; E/100 PY, events per 100 patient-years; MACE, major adverse cardiovascular event; NCI, National Cancer Institute; NMSC, non-melanoma skin cancer; PY, patient-years; TEAE, treatment-emergent adverse event.

^aAs assessed by the investigator.

^bAEs with NCI toxicity ≥grade 3 or unknown severity.

^cOf all fungal infection cases, fungal oesophagitis [n = 2] and oral fungal infection [n = 1] were also coded as opportunistic infections.

^dSerious anaphylactic reaction to intravenous iron carboxymaltose administration.