Table 4.
Treatment-emergent adverse events of safety interest
| TEAEs of safety interest | Double-blind perioda | Open-label perioda | ||||
|---|---|---|---|---|---|---|
| RZB 180 mg (n = 80) | RZB 360 mg (n = 80) | Placebo (n = 82) | RZB 180 mg/RZB 360 mg (n = 70) | RZB 360 mg/RZB 360 mg (n = 74) | Placebo/RZB 360 mg (n = 74) | |
| Adjudicated MACE | 0 | 0 | 0 | 0 | 0 | 0 |
| Adjudicated anaphylactic reaction | 0 | 0 | 0 | 0 | 0 | 0 |
| Serious infections | 2 (2.5) | 0 | 0 | 2 (2.9) | 0 | 2 (2.7) |
| Tuberculosis | 0 | 0 | 0 | 0 | 0 | 0 |
| Herpes zoster | 0 | 0 | 1 (1.2) | 0 | 0 | 1 (1.4) |
| Malignant tumor | 0 | 0 | 0 | 0 | 0 | 1 (1.4) |
| Serious hypersensitivity | 0 | 0 | 0 | 0 | 0 | 0 |
MACE Major adverse cardiovascular event
aValues are presented as the number (n) of patients with the percentage in parentheses