Table 4.
TEAE by system organ class and preferred term and key serious treatment-emergent adverse events (safety population)
| System organ class (preferred term) |
OKZ every 2 weeks N=143, n (%) |
OKZ every 4 weeks N=142, n (%) |
PBO N=142, n (%) |
| Number of subjects with at least one TEAE reported for 4% of subjects in any treatment group | 83 (58.0) | 81 (57.0) | 62 (43.7) |
| Investigations | 50 (35.0) | 51 (35.9) | 26 (18.3) |
| ALT increased | 25 (17.5) | 33 (23.2) | 11 (7.7) |
| AST increased | 16 (11.2) | 22 (15.5) | 10 (7.0) |
| White cell count decreased | 7 (4.9) | 6 (4.2) | 4 (2.8) |
| Neutrophil count decreased | 6 (4.2) | 7 (4.9) | 3 (2.1) |
| Blood cholesterol increased | 6 (4.2) | 4 (2.8) | 3 (2.1) |
| Gamma-glutamyltransferase increased | 3 (2.1) | 6 (4.2) | 4 (2.8) |
| Infections and infestations | 22 (15.4) | 20 (14.1) | 23 (16.2) |
| Nasopharyngitis | 4 (2.8) | 3 (2.1) | 6 (4.2) |
| Upper respiratory tract infection | 2 (1.4) | 6 (4.2) | 4 (2.8) |
| Blood and lymphatic system disorders | 17 (11.9) | 18 (12.7) | 15 (10.6) |
| Leucopenia | 8 (5.6) | 7 (4.9) | 4 (2.8) |
| Neutropaenia | 5 (3.5) | 9 (6.3) | 2 (1.4) |
| Anaemia | 4 (2.8) | 3 (2.1) | 6 (4.2) |
| Metabolism and nutrition disorders | 9 (6.3) | 7 (4.9) | 3 (2.1) |
| Musculoskeletal and connective tissue disorders | 6 (4.2) | 7 (4.9) | 6 (4.2) |
| Skin and subcutaneous tissue disorders | 8 (5.6) | 3 (2.1) | 2 (1.4) |
| Number and percentage with at least one key TESAE | 8 (5.6) | 8 (5.6) | 4 (2.8) |
| Investigations | 2 (1.4) | 4 (2.8) | 1 (0.7) |
| ALT increased | 2 (1.4) | 4 (2.8) | 1 (0.7) |
| AST increased | 0 | 3 (2.1) | 0 |
| Infections and infestations | 4 (2.8) | 0 | 2 (1.4) |
| Subcutaneous abscess | 2 (1.4) | 0 | 0 |
| Gastroenteritis | 0 | 0 | 1 (0.7) |
| Pneumonia | 0 | 0 | 1 (0.7) |
| Pulmonary tuberculosis | 1 (0.7) | 0 | 0 |
| Staphylococcal sepsis | 1 (0.7) | 0 | 0 |
| Toxic shock syndrome | 1 (0.7) | 0 | 0 |
| Herpes zoster | 0 | 0 | 0 |
| Hepatobiliary disorders | 0 | 1 (0.7) | 0 |
| Drug-induced liver injury | 0 | 1 (0.7) | 0 |
| Neoplasms benign, malignant and unspecified (including cysts and polyps) |
0 | 1 (0.7) | 0 |
| Cervix carcinoma stage II | 0 | 1 (0.7) | 0 |
| Gastrointestinal disorders | 0 | 1 (0.7) | 0 |
| Obstructive pancreatitis | 0 | 1 (0.7) | 0 |
| Gastrointestinal perforation | 0 | 0 | 0 |
| Vascular disorders | 0 | 1 (0.7) | 0 |
| Diabetic vascular disorder | 0 | 1 (0.7) | 0 |
| Venous thromboembolism | 0 | 0 | 0 |
| Death | 1 (0.7) | 0 | 0 |
All AEs were collected from the signature of the informed consent form until the last visit of the subject in the study (up to 22 weeks after the final dose of study treatment) regardless of relationship to study treatment, thus up to approximately 44 weeks.
A TEAE is defined as an AE that first occurred or worsened in severity after the first dose of the study treatment.
%, percentage of subjects calculated relative to the total number of subjects in the population.
MedDRA (Medical Dictionary for Regulatory Activities, V.21.1) was used to code AEs.
AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; n, number of subjects with events; N, number of subjects; OKZ, olokizumab; PBO, placebo; TEAE, treatment-emergent adverse event; TESAE, treatment-emergent serious adverse event.