Table 1.

TEAEs of special interest, as-treated set

TEAE, n (%) and EAIR per 100 PYE (95% CI)FIL 200 mgn=2267PYE=5302.5FIL 100 mgn=1647PYE=2782.6Total FILN=3691PYE=8085.1
Infectious AEs1206 (53.2)747 (45.4)1927 (52.2)
EAIR21.1 (19.7, 22.5)30.2 (26.8, 34.0)21.0 (19.9, 22.3)
Serious infectious AEs80 (3.5)57 (3.5)137 (3.7)
EAIR1.5 (1.1, 1.9)2.7 (1.9, 3.9)1.6 (1.3, 2.0)
Opportunistic infections5 (0.2)4 (0.2)9 (0.2)
EAIR0.1 (0, 0.2)*0.1 (0.1, 0.4)*0.1 (0.1, 0.2)*
Active tuberculosis03 (0.2)3 (<0.1)
EAIR00.1 (0, 0.3)*0 (0, 0.1)*
Herpes zoster84 (3.7)30 (1.8)114 (3.1)
EAIR1.6 (1.2, 2.0)1.1 (0.8, 1.5)*1.4 (1.1, 1.7)
Major adverse cardiovascular eventsa19 (0.8)14 (0.9)33 (0.9)
EAIR0.3 (0.2, 0.5)0.5 (0.3, 0.8)*0.4 (0.2, 0.6)
Venous thromboembolismb11 (0.5)4 (0.2)15 (0.4)
EAIR0.2 (0.1, 0.4)*0.1 (0.1, 0.4)*0.2 (0.1, 0.3)*
Atrial systemic thrombotic eventsa1 (<0.1)1 (<0.1)2 (<0.1)
EAIR0 (0, 0.1)0 (0, 0.3)0 (0, 0.1)
Malignancy excluding NMSC32 (1.4)17 (1.0)49 (1.3)
EAIR0.6 (0.4, 0.9)0.6 (0.4, 1.0)*0.6 (0.4, 0.8)
NMSC15 (0.7)5 (0.3)20 (0.5)
EAIR0.3 (0.2, 0.5)*0.2 (0.1, 0.4)*0.2 (0.2, 0.4)*
Gastrointestinal perforations3 (0.1)1 (<0.1)4 (0.1)
EAIR0.1 (0, 0.2)*0 (0, 0.3)*0 (0, 0.1)*

  • *Except when any study had 0 event within the treatment, the Poisson model was not adjusted by study. PYE was defined as (last dose date − first dose date + 1)/365.25.

  • ↵a Positively adjudicated.

  • ↵b Adjudicated as deep vein thrombosis or pulmonary embolism.

  • NMSC, nonmelanoma skin cancer