Table 3.

Rates of adverse events of interest through 3 years of treatment

AE	Overall safety population (n = 190; 412.2 patient-years)		MRI/CRP-positive safety subpopulation (n = 145; 320.9 patient-years)
	No. (%)	Events/100 patient-years	No. (%)	Events/100 patient-years
Serious AEs	33 (17.4)	10.9	25 (17.2)	9.7
Serious infection	8 (4.2)	2.4	6 (4.1)	2.2
Tuberculosis	1 (0.5)	0.2	1 (0.7)	0.3
Lupus-like reaction and systemic lupus erythematosus	1 (0.5)	0.2	1 (0.7)	0.3
Pulmonary embolism	1 (0.5)	0.2	1 (0.7)	0.3
New-onset psoriasis	2 (1.1)	0.5	1 (0.7)	0.3
Hepatic-related AEs	2 (1.1)	0.5	1 (0.7)	0.3
Diverticulitis	1 (0.5)	0.2	1 (0.7)	0.3
Death	2 (1.1)	0.5	2 (1.4)	0.6

Abbreviations: AE Adverse event, CRP C-reactive protein, MRI Magnetic resonance imaging

Includes all patients who received at least one dose of adalimumab, including patients who were excluded from the efficacy analyses because of noncompliance at the investigative site