|
AEs reported in ≥ 2 patients, n (%)
|
|
AEs attributed to glucocorticoids
|
|
Cataract
|
3 (5.0)
|
4 (6.7)
|
|
Impaired glucose metabolism
|
5 (8.3)
|
3 (5.0)
|
|
Psychiatric complications*
|
9 (15.0)
|
1 (1.7)
|
|
Gastroesophageal reflux disease
|
3 (5.0)
|
0
|
|
Gastrointestinal hemorrhage
|
1 (1.7)
|
2 (3.3)
|
|
Myopathy
|
4 (6.7)
|
1 (1.7)
|
|
Osteopenia
|
5 (8.3)
|
1 (1.7)
|
|
Atrial fibrillation
|
1 (1.7)
|
2 (3.3)
|
|
Hypertension
|
1 (1.7)
|
2 (3.3)
|
|
Cardiac failure
|
2 (3.3)
|
0
|
|
AEs attributed to glucocorticoids and/or TCZ
|
|
Dyslipidemia
|
0
|
2 (3.3)
|
|
Pneumonia
|
4 (6.7)
|
4 (6.7)
|
|
Urinary tract infection
|
1 (1.7)
|
2 (3.3)
|
|
Sinusitis
|
0
|
2 (3.3)
|
|
Herpes zoster infection
|
2 (3.3)
|
1 (1.7)
|
|
AEs attributed to TCZ
|
|
Leukopenia
|
0
|
3 (5.0)
|
|
Thrombocytopenia
|
0
|
2 (3.3)
|
|
Increased transaminases
|
0
|
3 (5.0)
|
|
AEs unrelated to glucocorticoids and/or TCZ
|
|
Osteoarthritis
|
0
|
3 (5.0)
|
|
Musculoskeletal pain
|
0
|
3 (5.0)
|
|
Deep vein thrombosis
|
0
|
2 (3.3)
|
|
Lumbar radiculopathy
|
0
|
2 (3.3)
|
|
SAEs reported in ≥ 1 patient, n (%)
|
6 (10.0)
|
6 (10.0)
|
|
SAEs attributed to glucocorticoids
|
|
Diabetic ketoacidosis
|
0
|
1 (1.7)
|
|
Gastrointestinal hemorrhage
|
0
|
2 (3.3)
|
|
Osteoporotic hip fracture
|
1 (1.7)
|
0
|
|
Depression
|
1 (1.7)
|
0
|
|
Atrial fibrillation
|
1 (1.7)
|
1 (1.7)
|
|
Cardiac failure
|
2 (3.3)
|
0
|
|
SAEs attributed to glucocorticoids and/or TCZ
|
|
Pneumocystis jiroveci pneumonia
|
1 (1.7)
|
0
|
|
Sepsis
|
0
|
1 (1.7)
|
|
SAEs attributed to TCZ
|
|
Leukopenia
|
0
|
1 (1.7)
|
|
Intestinal perforation
|
0
|
1 (1.7)
|
|
SAEs unrelated to glucocorticoids and/or TCZ
|
|
Acute kidney injury
|
0
|
1 (1.7)
|
|
Leiomyosarcoma
|
0
|
1 (1.7)
|
|
Pneumonitis
|
1 (1.7)
|
0
|
|
Pulmonary embolism
|
1 (1.7)
|
0
|
