Table 4.
Most Frequent Adverse Events Affecting 20% or More Patients Receiving Abiraterone Acetate (Zytiga) or Placebo
| Adverse Event | Abiraterone Acetate (n = 791) No. (%) | Placebo (n = 394) No. (%) | ||
|---|---|---|---|---|
| All Grades | Grades 3 and 4 | All Grades | Grades 3 and 4 | |
| Anemia | 178 (22.5) | 59 (7.5) | 104 (26.4) | 29 (7.4) |
| Thrombocytopenia | 28 (3.5) | 11 (1.4) | 13 (3.3) | 2 (0.5) |
| Diarrhea | 139 (17.6) | 5 (0.6) | 53 (13.5) | 5 (1.3) |
| Fatigue | 346 (43.7) | 66 (8.3) | 169 (42.9) | 39 (9.9) |
| Asthenia | 104 (13.1) | 18 (2.3) | 52 (13.2) | 8 (2.0) |
| Back pain | 233 (29.5) | 47 (5.9) | 129 (32.7) | 38 (9.6) |
| Nausea | 233 (29.5) | 13 (1.6) | 124 (3.1) | 10 (2.5) |
| Vomiting | 168 (21.2) | 14 (1.8) | 97 (24.6) | 11 (2.8) |
| Constipation | 206 (26.0) | 8 (1.0) | 120 (30.5) | 4 (1.0) |
| Arthralgia | 215 (27.2) | 33 (4.2) | 89 (22.6) | 16 (4.1) |
| Bone pain | 194 (24.5) | 44 (5.6) | 110 (27.9) | 29 (7.4) |
| Fluid retention and edema | 241 (30.5) | 18 (2.3) | 77 (19.5) | 4 (1.0) |
Adapted from de Bono JS, Logothetis CJ, Molina A, et al. N Engl J Med 2011;364(21):1995–2005.39