Table 2

Number and percentage of AE of interest by treatment group

AE, n (%) patientsADA+MTX (n=515)PBO+MTX (n=517)
Any AE379 (73.6)368 (71.2)
AE leading to discontinuation of study drug26 (5.0)15 (2.9)
Serious AE37 (7.2)32 (6.2)
Serious infectious AE13 (2.5)6 (1.2)
Opportunistic infections (excluding tuberculosis)1 (0.2)3 (0.6)
Tuberculosis1 (0.2)0
Malignancies (excluding NMSC)1 (0.2)0
NMSC1 (0.2)0
Congestive heart failure related1 (0.2)1 (0.2)
Fatal AE6 (1.2)*1 (0.2)
  • * Includes one non-treatment-emergent death.

  • ADA, adalimumab; AE, adverse events; MTX, methotrexate; NMSC, non-melanoma skin cancer; PBO, placebo.