Table 2.
Incidence of Most Common (> 10%) Adverse Events of Abiraterone Acetate in Patients With Castration-Resistant Prostate Cancer
| Adverse Event | All Grades (N = 33) |
Dose Cohort (No. of patients) |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 250 mg (n = 6) |
500 mg (n = 9) |
750 (n = 6) |
1,000 mg (n = 12) |
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| No. of Patients | % | Grade 1/2 | Grade 3 | Grade 1/2 | Grade 3/4 | Grade 1/2 | Grade 3 | Grade 1/2 | Grade 3 | |
| Abdominal pain | 6 | 18 | 1 | 2 | 2 | 1 | ||||
| Constipation | 7 | 21 | 2 | 1 | 2 | 2 | ||||
| Diarrhea | 10 | 30 | 3 | 2 | 1 | 4 | ||||
| Dry mouth | 7 | 21 | 2 | 3 | 2 | |||||
| Dyspepsia | 4 | 12 | 2 | 2 | ||||||
| Nausea | 11 | 33 | 1 | 3 | 1 | 6 | ||||
| Vomiting | 5 | 15 | 1 | 1 | 3 | |||||
| Asthenia | 8 | 24 | 1 | 3 | 2 | 2 | ||||
| Fatigue | 22 | 67 | 3 | 7 | 4 | 8 | ||||
| Edema | 5 | 15 | 1 | 3 | 1 | |||||
| Peripheral edema | 8 | 24 | 2 | 6 | ||||||
| Anorexia | 7 | 21 | 1 | 2 | 1 | 3 | ||||
| Hyperglycemia | 4 | 12 | 1 | 1 | 2 | |||||
| Hypokalemia | 8 | 24 | 1 | 3 | 1 | 2 | 1 | |||
| Arthralgia | 5 | 15 | 1 | 2 | 1 | 1 | ||||
| Back pain | 4 | 12 | 1 | 1 | 1 | 1 | ||||
| Muscular weakness | 5 | 15 | 2 | 1 | 1 | 1 | ||||
| Dizziness | 5 | 15 | 1 | 2 | 2 | |||||
| Headache | 11 | 33 | 3 | 2 | 6 | |||||
| Cough | 7 | 21 | 1 | 1 | 4 | 1 | ||||
| Hot flush | 7 | 21 | 2 | 2 | 3 | |||||
| Hypertension | 12 | 36 | 2 | 1 | 1 | 2 | 1 | 3 | 2 | |
| Hypotension | 4 | 12 | 1 | 3 | ||||||