Table 6.
Summary of adverse events in the safety analysis set
TCZ-SC group, n (%) | csDMARDs-alone group, n (%) | |
---|---|---|
n | 358 | 336 |
AEs | 127 (35.5) | 99 (29.5) |
Drug-related AEs | 85 (23.7) | – |
Serious AEs | 32 (8.9) | 11 (3.3) |
Serious drug-related AEs | 21 (5.9) | – |
AEs leading to discontinuation of study treatment | 33 (9.2) | 28 (8.3) |
Drug-related AEs leading to discontinuation of study treatment | 29 (8.1) | – |
AE adverse event, csDMARD conventional synthetic disease-modifying antirheumatic drug, TCZ-SC tocilizumab by subcutaneous injection