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 TEAE | 74 (53.2) | 88 (55.0) | 35 (50.7) |
| Blood and lymphatic system disorders | 7 (5.0) | 8 (5.0) | 5 (7.2) |
| Gastrointestinal disorders | 12 (8.6) | 10 (6.2) | 6 (8.7) |
| General disorders and administration site conditions | 7 (5.0) | 12 (7.5) | 3 (4.3) |
| Hepatobiliary disorders | 6 (4.3) | 5 (3.1) | 1 (1.4) |
| Infections and infestations | 28 (20.1) | 36 (22.5) | 18 (26.1) |
| Injury, poisoning and procedural complications | 3 (2.2) | 10 (6.2) | 1 (1.4) |
| Investigations | 21 (15.1) | 21 (13.1) | 4 (5.8) |
| Metabolism and nutrition disorders | 9 (6.5) | 11 (6.9) | 1 (1.4) |
| Musculoskeletal and connective tissue disorders | 9 (6.5) | 8 (5.0) | 5 (7.2) |
| Nervous system disorders | 3 (2.2) | 5 (3.1) | 2 (2.9) |
| Skin and subcutaneous tissue disorders | 9 (6.5) | 12 (7.5) | 1 (1.4) |
| Vascular disorders | 4 (2.9) | 3 (1.9) | 3 (4.3) |
| TEAE, leading to death | 0 | 0 | 0 |
| 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.