Table 32 (abstract P320). See text for description
From: Proceedings of the 23rd Paediatric Rheumatology European Society Congress: part two
Table. | MTX | ADA ± MTX | ||
|---|---|---|---|---|
N = 303 n (%) | PYs = 1014.6 E (E/100 PYs) | N = 543 n (%) | PYs = 1562.7 E (E/100 PYs) | |
Any AE | 156 (51.5) | 470 (46.3) | 229 (42.2) | 683 (43.7) |
At least “possibly drug related” per the investigator | 83 (27.4) | 171 (16.9) | 110 (20.3) | 222 (14.2) |
Severe AE | 14 (4.6) | 18 (1.8) | 34 (6.3) | 55 (3.5) |
Serious AE | 29 (9.6) | 45 (4.4) | 66 (12.2) | 117 (7.5) |
AE leading to discontinuation of study drug or study | 25 (8.3) | 33 (3.3) | 35 (6.4) | 56 (3.6) |
Infectious AE | 85 (28.1) | 164 (16.2) | 134 (24.7) | 226 (14.5) |
Serious infectious AE | 12 (4.0) | 15 (1.5) | 26 (4.8) | 36 (2.3) |
Injection site-related AE | 6 (2.0)* | 8 (0.8) | 28 (5.2) | 37 (2.4) |