MedDRA (V.14.0) System organ class preferred term | Dosing frequency | PBO n/N (%) | OKZ 60 mg n/N (%) | OKZ 120 mg n/N (%) | OKZ 240 mg n/N (%) | TCZ 8 mg/kg n/N (%) |
---|---|---|---|---|---|---|
Liver function tests | ||||||
Alanine aminotransferase increased | Q2W | 0 | 0 | 0 | 0 | – |
Q4W | 0 | 1/22 (4.5) | 0 | 0 | 0 | |
Aspartate aminotransferase increased | Q2W | 0 | 0 | 0 | 0 | – |
Q4W | 0 | 1/22 (4.5) | 0 | 0 | 0 | |
γ glutamyl transferase increased | Q2W | 0 | 0 | 0 | 0 | – |
Q4W | 0 | 1/22 (4.5) | 0 | 1/22 (4.5) | 1/43 (2.3) | |
Haematology | ||||||
Neutrophil count decreased | Q2W | 0 | 0 | 0 | 0 | – |
Q4W | 0 | 1/22 (4.5) | 0 | 0 | 2/43 (4.7) | |
Leukocyte count decreased | Q2W | 0 | 0 | 0 | 0 | – |
Q4W | 0 | 0 | 0 | 0 | 0 | |
Lipids | ||||||
Total cholesterol increased | Q2W | 1/22 (4.5) | 0 | 0 | 1/23 (4.3) | – |
Q4W | 0 | 1/22 (4.5) | 0 | 1/22 (4.5) | 0 | |
Low density lipoprotein increased | Q2W | 0 | 0 | 0 | 0 | – |
Q4W | 0 | 0 | 0 | 0 | 0 | |
High density lipoprotein increase | Q2W | 0 | 0 | 0 | 0 | – |
Q4W | 0 | 0 | 0 | 0 | 0 | |
Triglycerides increased | Q2W | 0 | 0 | 0 | 0 | – |
Q4W | 0 | 0 | 0 | 0 | 0 |
*National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) V.4. Markedly abnormal values are those graded 3 or 4 and worse than baseline value.
OKZ, olokizumab; PBO, placebo; TCZ, tocilizumab.