Summary of treatment-emergent adverse events of interest: safety analysis set
| Period 2 | Period 3 | Overall | ||||||
|---|---|---|---|---|---|---|---|---|
| FKB327 N=324 | RP N=321 | Total N=645 | FKB327 N=572 | FKB327 N=614 673.7495 pt-yrs | RP N=321 175.3812 pt-yrs | |||
| Patients n (%) | Patients n (%) | Patients n (%) | Patients n (%) | Patients n (%) | Events n (IR) | Patients n (%) | Events n (IR) | |
| ≥1 Infections | 72 (22.2) | 90 (28.0) | 162 (25.1) | 189 (33.0) | 227 (37.0) | 375 (0.557) | 90 (28.0) | 120 (0.684) |
| ≥1 Serious infections (including TB) | 3 (0.9) | 5 (1.6) | 8 (1.2) | 7 (1.2) | 10 (1.6) | 16 (0.024) | 5 (1.6) | 5 (0.029) |
| ≥1 Malignancies or lymphoproliferative disorders | 1 (0.3) | 0 | 1 (0.2) | 2 (0.3) | 3 (0.5) | 3 (0.004) | 0 | 0 |
| ≥1 Injection-site reactions to study drug (related or possibly related) | 4 (1.2) | 5 (1.6) | 9 (1.4) | 7 (1.2) | 10 (1.6) | 40 (0.059) | 5 (1.6) | 14 (0.080) |
| ≥1 Potential hypersensitivity reactions or anaphylaxes to study drug (related or possibly related) | 1 (0.3) | 6 (1.9) | 7 (1.1) | 4 (0.7) | 5 (0.8) | 6 (0.009) | 6 (1.9) | 8 (0.046) |
| ≥1 Neutropaenia events | 4 (1.2) | 1 (0.3) | 5 (0.8) | 3 (0.5) | 6 (1.0) | 8 (0.012) | 1 (0.3) | 1 (0.006) |
| ≥1 New or worsening congestive heart failure events | 0 | 1 (0.3) | 1 (0.2) | 0 | 0 | 0 | 1 (0.3) | 2 (0.011) |
IR, incidence rate (events/patient-year); pt-yrs, patient-years; RP, reference product; TB, tuberculosis.