Table 4.
Summary of most common adverse events in the Japanese subgroup (safety population)
| Most common adverse eventsan (%) | AAP (N = 35) | Placebo (N = 35) | ||||
|---|---|---|---|---|---|---|
| All grades | Grade 3 | Grade 4 | All grades | Grade 3 | Grade 4 | |
| Hypertension | 18 (51.4) | 12 (34.3) | 0 | 8 (22.9) | 2 (5.7) | 0 |
| Nasopharyngitis | 13 (37.1) | 0 | 0 | 11 (31.4) | 0 | 0 |
| Hypokalemia | 12 (34.3) | 3 (8.6) | 1 (2.9) | 0 | 0 | 0 |
| Weight gain | 12 (34.3) | 0 | 0 | 12 (34.3) | 2 (5.7) | 0 |
| Hot flush | 11 (31.4) | 0 | 0 | 11 (31.4) | 0 | 0 |
| Back pain | 10 (28.6) | 0 | 0 | 7 (20.0) | 0 | 0 |
| Hyperglycemia | 8 (22.9) | 4 (11.4) | 0 | 5 (14.3) | 1 (2.9) | 0 |
| ALT increased | 8 (22.9) | 1 (2.9) | 0 | 11 (31.4) | 1 (2.9) | 0 |
| AST increased | 8 (22.9) | 1 (2.9) | 0 | 10 (28.6) | 1 (2.9) | 0 |
| Insomnia | 5 (14.3) | 0 | 0 | 3 (8.6) | 0 | 0 |
| Rib fracture | 5 (14.3) | 0 | 0 | 1 (2.9) | 0 | 0 |
| Constipation | 4 (11.4) | 0 | 0 | 4 (11.4) | 4 (11.4) | 0 |
| Dental caries | 4 (11.4) | 1 (2.9) | 0 | 4 (11.4) | 2 (5.7) | 0 |
| Diarrhea | 4 (11.4) | 1 (2.9) | 0 | 4 (11.4) | 2 (5.7) | 0 |
| Vomiting | 4 (11.4) | 0 | 0 | 4 (11.4) | 1 (2.9) | 0 |
| Hematuria | 4 (11.4) | 0 | 0 | 0 | 0 | 0 |
| Hyperbilirubinemia | 4 (11.4) | 0 | 0 | 0 | 0 | 0 |
AAP, abiraterone acetate plus prednisone; AEs, adverse events; ALT, alanine aminotransferase; AST, aspartate aminotransferase.
aAdverse events reported by CTCAE toxicity grades.