Table 3

Treatment-emergent adverse events and serious treatment-emergent adverse events (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 (%)
Any TEAEsQ2W19/22 (86.4)14/20 (70.0)14/22 (63.6)19/23 (82.6)
Q4W17/22 (77.3)18/22 (81.8)20/23 (87.0)19/22 (86.4)37/43 (86.0)
 Gastrointestinal disordersQ2W7/22 (31.8)3/20 (15.0)3/22 (13.6)5/23 (21.7)
Q4W2/22 (9.1)3/22 (13.6)4/23 (17.4)8/22 (36.4)9/43 (20.9)
 General disorders and administration site reactionsQ2W4/22 (18.2)5/20 (25.0)5/22 (22.7)11/23 (47.8)
Q4W4/22 (18.2)9/22 (40.9)4/23 (17.4)6/22 (27.3)9/43 (20.9)
 Infections and infestationsQ2W7/22 (31.8)5/20 (25.0)6/22 (27.3)7/23 (30.4)
Q4W11/22 (50.0)6/22 (27.3)8/23 (34.8)8/22 (36.4)16/43 (37.2)
Serious TEAEsQ2W2 (9.1)3 (15.0)00
Q4W1 (4.5)1 (4.5)02 (9.1)4 (9.3)
 AnaemiaQ2W0000
Q4W1/22 (4.5)0000
 InvestigationsQ2W0000
Q4W01/22 (4.5)001/43 (2.3)
  Liver function test abnormalQ2W0000
Q4W01/22 (4.5)000
  Blood triglycerides increasedQ2W0000
Q4W00001/43 (2.3)
 Infections and infestationsQ2W0000
Q4W0002/22 (9.1)2/43 (4.7)
  PneumoniaQ2W0000
Q4W0001/22 (4.5)1/43 (2.3)
 Neoplasms, benign malignant and unspecifiedQ2W01/20 (5.0)00
Q4W00000
  Basal cell carcinomaQ2W01/20 (5.0)00
Q4W00000
DeathsQ2W0000
Q4W00000
  • OKZ, olokizumab; PBO, placebo; TCZ, tocilizumab; TEAE, treatment emergent adverse event.