Table 3. AEs Reported During the 1-Year Treatment Period by Gradea.
| Characteristic | No. (%) | |||||||
|---|---|---|---|---|---|---|---|---|
| Enzalutamide, 160 mg (n = 112) | AS (n = 113) | |||||||
| Gradeb | Total | Gradeb | Total | |||||
| 1 | 2 | ≥3 | 1 | 2 | ≥3 | |||
| Any AE | 34 (30.4) | 58 (51.8) | 11 (9.8)c | 103 (92.0) | 27 (23.9) | 25 (22.1) | 10 (8.8)d | 62 (54.9) |
| Drug-related AEs | 47 (42.0) | 46 (41.1) | 6 (5.4) | 99 (88.4) | NA | NA | NA | NA |
| AEs reported in ≥5% of patients in any treatment arme | ||||||||
| Fatigue | 49 (43.8) | 11 (9.8) | 2 (1.8) | 62 (55.4) | 3 (2.7) | 1 (0.9) | 0 | 4 (3.5) |
| Gynecomastia | 26 (23.2) | 14 (12.5) | 1 (0.9) | 41 (36.6) | 2 (1.8) | 0 | 0 | 2 (1.8) |
| Nipple pain | 30 (26.8) | 4 (3.6) | 0 | 34 (30.4) | 0 | 0 | 0 | 0 |
| Breast tenderness | 25 (22.3) | 4 (3.6) | 0 | 29 (25.9) | 1 (0.9) | 0 | 0 | 1 (0.9) |
| Erectile dysfunction | 9 (8.0) | 11 (9.8) | 0 | 20 (17.9) | 2 (1.8) | 0 | 0 | 2 (1.8) |
| Alopecia | 10 (8.9) | 1 (0.9) | 0 | 11 (9.8) | 0 | 0 | 0 | 0 |
| Decreased libido | 8 (7.1) | 1 (0.9) | 0 | 9 (8.0) | 1 (0.9) | 0 | 0 | 1 (0.9) |
| Hypertension | 3 (2.7) | 5 (4.5) | 0 | 8 (7.1) | 3 (2.7) | 2 (1.8) | 3 (2.7) | 8 (7.1) |
| Breast enlargement | 5 (4.5) | 2 (1.8) | 0 | 7 (6.3) | 0 | 0 | 0 | 0 |
| Diarrhea | 3 (2.7) | 3 (2.7) | 0 | 6 (5.4) | 0 | 0 | 0 | 0 |
| Hot flush | 4 (3.6) | 2 (1.8) | 0 | 6 (5.4) | 0 | 0 | 0 | 0 |
| Nausea | 6 (5.4) | 0 | 0 | 6 (5.4) | 0 | 0 | 0 | 0 |
| Pollakiuria | 4 (3.6) | 2 (1.8) | 0 | 6 (5.4) | 3 (2.7) | 1 (0.9) | 0 | 4 (3.5) |
| Upper respiratory tract infection | 4 (3.6) | 2 (1.8) | 0 | 6 (5.4) | 2 (1.8) | 2 (1.8) | 0 | 4 (3.5) |
| Weight decreased | 4 (3.6) | 2 (1.8) | 0 | 6 (5.4) | 0 | 0 | 0 | 0 |
Abbreviations: AE, adverse event; AS, active surveillance; NA, not applicable.
a
The 1-year treatment period was defined as from the date of the first dose (enzalutamide) or randomization (AS) until the date discontinued or completed 12 months on study +30 days.
b
Adverse events were graded based on the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.
c
Including 10 grade 3 AEs and 1 grade 5 AE (death).
d
Including 9 grade 3 AEs and 1 grade 4 AE.
e
Adverse events were coded using the Medical Dictionary for Regulatory Activities, version 23.0.