Table 1.

EAIRs of TEAEs in LTE, as of June 1, 2020

1TEAE, n (%)3FIL200+MTX → FIL200+MTX6ADA+MTX → FIL200+MTX9FIL100+MTX → FIL100+MTX12ADA+MTX → FIL100+MTX
2EAIR (95% CI)4n=5717n=12810n=57013n=130
5PYE=859.48PYE=197.811PYE=852.314PYE=192.6
TEAE429 (75.1)91 (71.1)443 (77.7)88 (67.7)
49.9 (45.4, 54.9)46.0 (37.5, 56.5)52.0 (47.4, 57.0)45.7 (37.1, 56.3)
TEAE Grade ≥364 (11.2)15 (11.7)72 (12.6)7 (5.4)
7.4 (5.8, 9.5)7.6 (4.6, 12.6)8.4 (6.7, 10.6)3.6 (1.7, 7.6)
TE serious AE52 (9.1)13 (10.2)60 (10.5)9 (6.9)
6.1 (4.6, 7.9)6.6 (3.8, 11.3)7.0 (5.5, 9.1)4.7 (2.4, 9.0)
Death3 (0.5)2 (1.6)3 (0.5)2 (1.5)
0.3 (0.1, 1.1)1.0 (0.3, 4.0)0.4 (0.1, 1.1)1.0 (0.3, 4.2)
TE infections243 (42.6)52 (40.6)249 (43.7)43 (33.1)
28.3 (24.9, 32.1)26.3 (20.0, 34.5)29.2 (25.8, 33.1)22.3 (16.6, 30.1)
TE serious infections7 (1.2)2 (1.6)13 (2.3)1 (0.8)
0.8 (0.4, 1.7)1.0 (0.3, 4.0)1.5 (0.9, 2.6)0.5 (0.1, 3.7)
Opportunistic infections2 (0.4)02 (0.4)0
0.2 (0, 0.8)0 (0, 1.9)0.2 (0, 0.8)0 (0, 1.9)
TE herpes zoster16 (2.8)5 (3.9)13 (2.3)1 (0.8)
1.9 (1.1, 3.0)2.5 (1.1,6.1)1.5 (0.9, 2.6)0.5 (0.1, 3.7)
TE MACE (adjudicated)1 (0.2)03 (0.5)3 (2.3)
01 (0, 0.6)0 (0, 1.9)0.4 (0.1, 1.1)1.6 (0.5, 4.8)
TE DVT/PE (adjudicated)3 (0.5)03 (0.5)0
0.3 (0.1, 1.0)0 (0, 1.9)0.4 (0.1, 1.0)0 (0, 1.9)
Malignancies (excluding NMSC)5 (0.9)3 (2.3)4 (0.7)0
0.6 (0.2, 1.4)1.5 (0.5, 4.7)0.5 (0.1, 1.2)0 (0, 1.9)
NMSC3 (0.5)02 (0.4)0
0.3 (0.1, 1.0)0 (0, 1.9)0.2 (0, 0.8)0 (0, 1.9)
  • DVT, deep vein thrombosis; MACE, major adverse cardiovascular event; NMSC, nonmelanoma skin cancer; PE, pulmonary embolism; TE, treatment-emergent