Table 4

Markedly abnormal laboratory values (laboratory values graded 3 or 4 according to CTCAE* V.4.0) (safety set)

MedDRA (V.14.0)
System organ class
preferred term
Dosing frequencyPBO
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 increasedQ2W0000
Q4W01/22 (4.5)000
 Aspartate aminotransferase increasedQ2W0000
Q4W01/22 (4.5)000
 γ glutamyl transferase increasedQ2W0000
Q4W01/22 (4.5)01/22 (4.5)1/43 (2.3)
Haematology
 Neutrophil count decreasedQ2W0000
Q4W01/22 (4.5)002/43 (4.7)
 Leukocyte count decreasedQ2W0000
Q4W00000
Lipids
 Total cholesterol increasedQ2W1/22 (4.5)001/23 (4.3)
Q4W01/22 (4.5)01/22 (4.5)0
 Low density lipoprotein increasedQ2W0000
Q4W00000
 High density lipoprotein increaseQ2W0000
Q4W00000
 Triglycerides increasedQ2W0000
Q4W00000
  • *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.