Table 4

Incidence of treatment-emergent adverse events by system organ class in >than 3% of patients and serious adverse events up to week 16 (safety population)

System organ class, n (%)OKZ q2w
n=139
OKZ q4w
n=160
PBO
n=69
Subjects with ≥1 TEAE74 (53.2)88 (55.0)35 (50.7)
 Blood and lymphatic system disorders7 (5.0)8 (5.0)5 (7.2)
 Gastrointestinal disorders12 (8.6)10 (6.2)6 (8.7)
 General disorders and administration site conditions7 (5.0)12 (7.5)3 (4.3)
 Hepatobiliary disorders6 (4.3)5 (3.1)1 (1.4)
 Infections and infestations28 (20.1)36 (22.5)18 (26.1)
 Injury, poisoning and procedural complications3 (2.2)10 (6.2)1 (1.4)
 Investigations21 (15.1)21 (13.1)4 (5.8)
 Metabolism and nutrition disorders9 (6.5)11 (6.9)1 (1.4)
 Musculoskeletal and connective tissue disorders9 (6.5)8 (5.0)5 (7.2)
 Nervous system disorders3 (2.2)5 (3.1)2 (2.9)
 Skin and subcutaneous tissue disorders9 (6.5)12 (7.5)1 (1.4)
 Vascular disorders4 (2.9)3 (1.9)3 (4.3)
TEAE, leading to death000
Subjects with ≥1 TESAE*9 (6.5)3 (1.9)0
  • n, number of subjects; %, percentage of subjects calculated relative to the total number of subjects in the treatment arm. MedDRA (Medical Dictionary for Regulatory Activities) V.21.1 was used to code AEs. A TEAE is defined as an AE that first occurred or worsened in severity after the first dose of the study treatment.

  • *TEASE by organ class/preferred term were: 1 pt with hepatobiliary disorders/cholecystitis; 1 pt with immune system disorders/anaphylactic reaction; 3 pts with infections and infestations/cellulitis (1pt), pilonidal cyst (1pt), sepsis (1pt); 3 pts with investigations/alanine aminotransferase increased (1pt), aspartate aminotransferase increased (1pt), transaminases increased (1pt); 2 pts with musculoskeletal and connective tissue disorders/intervertebral disc protrusion (1pt), musculoskeletal chest pain (1pt); 1pt with psychiatric disorders/anxiety and 1 pt with vascular disorders/hypertensive crisis.

  • pt, patient; TEAE, treatment-emergent adverse event; TESAE, treatment-emergent serious adverse event.