Table 5. Summary of adverse events.
| Parameter | PREVAIL (n=1,715) [6] | PREVAIL Korean (n=78) [10] | Current study (n=199) | ||
|---|---|---|---|---|---|
| ENZA (n=871) | Placebo (n=844) | ENZA (n=40) | Placebo (n=38) | ||
| Median duration of treatment (mo) | 16.6 | 4.6 | 13.0 | 5.1 | 5.0 |
| Any AEs | 844 (96.9) | 787 (93.2) | 37 (92.5) | 30 (78.9) | 59 (34.9) |
| Missing | 30 | ||||
| Serious AEs | 279 (32.0) | 226 (26.8) | 14 (35.0) | 3 (7.9) | 3 (1.7) |
| Missing | 22 | ||||
| Grade ≥3 AEs | 374 (42.9) | 313 (37.1) | 13 (32.5) | 4 (10.5) | 3 (1.8) |
| Missing | 30 | ||||
| Drug-related grade ≥3 AEs | 67 (7.7) | 54 (6.4) | 0 (0.0) | 0 (0.0) | 3 (1.7) |
| Missing | 23 | ||||
| Most common AEs | |||||
| Musculoskeletal pain | 87 (10.0) | 73 (8.6) | 4 (10.0) | 2 (5.3) | 8 (4.7) |
| Fatigue | 310 (35.6) | 218 (25.8) | 8 (20.0) | 4 (10.5) | 6 (3.6) |
| Decreased appetite | 158 (18.1) | 136 (16.1) | Unknown | Unknown | 5 (3.0) |
| Constipation | 193 (22.2) | 145 (17.2) | 6 (15.0) | 2 (5.3) | 2 (1.2) |
| Diarrhea | 142 (16.3) | 119 (14.1) | Unknown | Unknown | 2 (1.2) |
| Hypertension | 117 (13.4) | 35 (4.1) | Unknown | Unknown | 2 (1.2) |
| Hot flush | 157 (18.0) | 65 (7.7) | 5 (12.5) | 2 (5.3) | 2 (1.2) |
| Headache | 91 (10.4) | 59 (7.0) | Unknown | Unknown | 2 (1.2) |
| Back pain | 235 (27.0) | 187 (22.2) | 7 (17.5) | 3 (7.9) | 1 (0.6) |
| Nausea | 201 (23.1) | 190 (22.5) | 6 (15.0) | 4 (10.5) | 1 (0.6) |
| Asthenia | 113 (13.0) | 67 (7.9) | Unknown | Unknown | 1 (0.6) |
| Upper respiratory infection | 53 (6.1) | 30 (3.6) | 8 (20.0) | 3 (7.9) | 0 (0.0) |
Values are presented as number only or number (%).
ENZA, enzalutamide; AE, adverse event.