Table. Primary End Point: Mineralocorticoid Excess Adverse Events During the First 24 Weeks.
| Variable | Treatment Groupa | |||
|---|---|---|---|---|
| Prednisone, 5 mg, Twice Daily (n = 34)b | Prednisone, 5 mg, Once Daily (n = 38)b | Prednisone, 2.5 mg, Twice Daily (n = 35)b | Dexamethasone, 0.5 mg, Once Daily (n = 37)b | |
| Met the primary end pointc | ||||
| No. (%) | 24 (71) | 14 (37) | 21 (60) | 26 (70) |
| 95% CI | (54-83) | (23-53) | (44-74) | (54-83) |
| Investigator reported an adverse event | ||||
| Grade ≥2 hypertension and grade ≥1 hypokalemia, No. (%) | 2 (6) | 1 (3) | 3 (9) | 2 (5) |
| Grade ≥2 hypertension alone, No. (%) | 7 (21) | 18 (47) | 10 (29) | 6 (16) |
| Grade ≥1 hypokalemia alone, No. (%) | 1 (3) | 5 (13) | 1 (3) | 3 (8) |
a
Patients in all treatment groups received abiraterone acetate.
b
Patients completed the 24 weeks of treatment (6 cycles) or discontinued treatment early and experienced either hypertension (National Cancer Institute Common Terminology Criteria for Adverse Events grade ≥2) or hypokalemia.
c
Investigator reported neither hypertension (National Cancer Institute Common Terminology Criteria for Adverse Events grade ≥2) nor hypokalemia during the first 24 weeks (6 cycles).