Table 2.
Treatment-related adverse events.a
| Adverse event | ARM 1: AAP (n = 37) |
ARM 2: AAP + D (n = 41) |
ARM 3: D (n = 42) |
All cohorts (N = 120) | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | Grade 1 | Grade 2 | Grade 3 | Grade 1 | Grade 2 | Grade 3 | Any grade | |
| Hot flashes | 21 (57) | 1 (3) | – | 28 (68) | 5 (12) | – | 35 (83) | 2 (5) | – | 92 (77) |
| Fatigue | 16 (43) | 1 (3) | – | 16 (39) | 2 (5) | – | 24 (57) | 1 (2) | 1 (2) | 61 (51) |
| Injection site reaction | – | – | – | 9 (22) | 1 (2) | – | 9 (21) | – | – | 19 (16) |
| ALT increased | 4 (11) | 2 (5) | 2 (5) | 3 (7) | 2 (5) | 2 (5) | 4 (10) | – | – | 19 (16) |
| Hypertension | 2 (5) | 4 (11) | 1 (3) | 2 (5) | 4 (10) | 2 (5) | 1 (2) | 1 (2) | 1 (2) | 18 (15) |
| AST increased | 7 (19) | 1 (3) | 1 (3) | 4 (10) | 1 (2) | 1 (2) | 3 (7) | – | – | 18 (15) |
| Insomnia | 5 (14) | – | 1 (3) | 3 (7) | – | – | 6 (14) | 1 (2) | – | 16 (13) |
| Depression | 2 (5) | – | – | 2 (5) | 1 (2) | – | 3 (7) | 2 (5) | – | 10 (8) |
| Nausea | 4 (11) | – | – | 4 (10) | – | – | – | – | – | 8 (7) |
| Hyperglycemia | – | 1 (3) | – | 1 (2) | 1 (2) | 2 (5) | – | 1 (2) | 1 (2) | 7 (6) |
| Breast pain | 5 (14) | 2 (5) | – | – | – | – | – | – | – | 7 (6) |
| Urinary frequency | 3 (8) | 1 (3) | – | – | 1 (2) | – | 1 (2) | – | – | 6 (5) |
| Anemia | 1 (3) | – | 1 (3) | 1 (2) | – | – | 3 (7) | – | – | 6 (5) |
| Gynecomastia | 4 (11) | – | – | 1 (2) | – | – | 1 (2) | – | – | 6 (5) |
| Headache | 2 (5) | 1 (3) | – | 2 (5) | – | – | 1 (2) | – | – | 6 (5) |
AAP = abiraterone acetate plus prednisone; ALT = alanine aminotransferase; AST = aspartate transaminase; CTCAE = Common Terminology Criteria for Adverse Events; D = degarelix.
Data are presented as n (%).
a
Adverse events are reported only if they occurred in >5% of the overall patient population. CTCAE version 4.0 was used for this trial.