Table 8.
Proportion of patients with Grade 3 or 4 laboratory abnormalities (National Cancer Institute-Common Terminology for Adverse Events version 4.03) (safety population [Part A])
| Grade 3 or 4 laboratory abnormality | Sirukumab 100 mg q2w + 6-month prednisone (n = 42) | Sirukumab 100 mg q2w + 3-month prednisone (n = 39) | Sirukumab 50 mg q4w + 6-month prednisone (n = 26) | 6-month prednisone (n = 27) | 12-month prednisone (n = 27) | Total (N = 161) |
|---|---|---|---|---|---|---|
| Haematology (decreased), n (%) | ||||||
| Leukocytes (109/l) | 0 | 1 (2.6) | 0 | 0 | 0 | 1 (0.6) |
| Lymphocytes (109/l) | 1 (2.4) | 1 (2.6) | 1 (3.8) | 0 | 1 (3.7) | 4 (2.5) |
| Neutrophils (109/l) | 0 | 1 (2.6) | 0 | 0 | 0 | 1 (0.6) |
| Platelets (109/l) | 0 | 1 (2.6) | 0 | 0 | 0 | 1 (0.6) |
| Liver function tests (increased), n (%) | ||||||
| ALT (IU/l) | 1 (2.4) | 0 | 0 | 0 | 0 | 1 (0.6) |
| Bilirubin (µmol/l) | 2 (4.8) | 0 | 0 | 0 | 0 | 2 (1.2) |
| Lipids (increased), n (%) | ||||||
| n | 41 | 38 | 26 | 27 | 27 | 159 |
| Cholesterol (mmol/l) | 0 | 2 (5.3) | 0 | 0 | 0 | 2 (1.3) |
| Triglycerides (mmol/l) | 1 (2.4) | 0 | 1 (3.8) | 0 | 0 | 2 (1.3) |
| Other, n (%) | ||||||
| Glucose (increased) (mmol/l) | 0 | 1 (2.6) | 0 | 1 (3.7) | 3 (11.1) | 5 (3.1) |
| Phosphate (decreased) (mmol/l) | 0 | 1 (2.6) | 0 | 1 (3.7) | 0 | 2 (1.2) |
| Potassium (increased) (mmol/l) | 0 | 1 (2.6) | 0 | 0 | 0 | 1 (0.6) |
| Sodium (decreased) (mmol/l) | 0 | 1 (2.6) | 1 (3.8) | 1 (3.7) | 0 | 3 (1.9) |
ALT alanine aminotransferase, q2w every 2 weeks, q4w every 4 weeks