(N=65) | |
Patients with ≥1 AE | 48 (73.8) |
Total no of non-serious AEs | 121 |
Related or possibly related to prednisone exclusively* | 23 (19.0) |
Related or possibly related to TCZ exclusively* | 48 (39.7) |
Related or possibly related to prednisone or TCZ* | 9 (7.4) |
Patients with ≥1 SAE | 11 (16.9) |
Total no of SAEs | 13 |
Related or possibly related to prednisone exclusively† | 3 (23.1) |
Diabetic ketoacidosis | 1 |
Stroke | 1 |
Vertebral fracture | 1 |
Related or possibly related to TCZ exclusively† | 4 (30.8) |
Bacteraemia of unclear source | 1 |
COVID-19 | 1 |
Diverticulitis | 1 |
Postsurgical skin and soft-tissue infection | 1 |
Related or possibly related to prednisone or TCZ† | 2 (15.4) |
Pneumonia | 1 |
Sepsis from urinary tract infection | 1 |
All values represent number (%).
*The denominator for the AE proportions is 121 total AEs.
†The denominator for the SAE proportions is 13 total SAEs.
AE, adverse event; GCA, giant cell arteritis; SAE, serious adverse event; TCZ, tocilizumab.