. 2023 Jan 11;8(3):215–227. doi: 10.1016/S2468-1253(22)00385-5

Table 3.

Serious adverse events in all randomised patients (n=211)

	Combination group (n=71)	Infliximab withdrawal group (n=71)	Immunosuppressant withdrawal group (n=69)
Infections	4 (6%)^*	2 (3%)^*	1 (1%)^*
Allergic reaction to infliximab	0	0	1 (1%)
Crohn's disease exacerbation	3 (4%)	4 (6%)	1 (1%)
Cancer	0	0	0
Death	0	0	0
Miscellaneous	3 (4%)^†	2 (3%)^†	10 (14%)^†

Data are number of events (%).

Infections: four cases of appendicitis in the combination group; one case of viral pericarditis and one community-acquired pneumonia in the infliximab withdrawal group; and one report of tuberculosis in the immunosuppressant withdrawal group.

^†

Miscellaneous includes renal insufficiency (n=2) and gastric sleeve surgery (n=1) in the combination group; ischaemic stroke (n=1) and brachial neuralgia (n=1) in the infliximab withdrawal group; and acute pancreatitis (n=2), alcohol intoxication (n=4), cannabis intoxication (n=1), epilepsy (n=1), sacrococcygeal cyst (n=1), and spontaneous miscarriage (n=1) in the immunosuppressant withdrawal group.