Table 5.

Summary of AEs

	Abiraterone Acetate + Prednisone(N=131)
Patients with AEs, n (%)	126(96.2)
Drug-related	118(90.1)
Patients with serious AEs, n (%)	57 (43.5)
Drug-related	29(22.1)
Patients with AEs leading to treatment discontinuation, n (%)	20(15.3)
Patients with AEs leading to death, n (%)*	7(5.3)
Common AEs (≥15% of patients)	Any Grade	Grade ≥3
Hypertension	55 (42.0)	31 (23.7)
Fatigue	52 (39.7)	1 (0.8)
Hypokalemia	44 (33.6)	9 (6.9)
Peripheral edema	33 (25.2)	2(1.5)
Nausea	28 (21.4)	1 (0.8)
Diarrhea	25 (19.1)	2(1.5)
Dizziness	25 (19.1)	1 (0.8)
Headache	22 (16.8)	1 (0.8)
Constipation	22 (16.8)	1 (0.8)
Cough	22 (16.8)	0
Back pain	21 (16.0)	2(1.5)
Vomiting	21 (16.0)	1 (0.8)
Upper respiratory tract infection	21 (16.0)	0
Arthralgia	20(15.3)	0
AEs of hypertension, hypokalemia, and fluid retention or edema events of special interest	Any Grade	Grade 3**
Hypertension	55 (42.0)	31 (23.7)
Hypertensive crisis	1 (0.8)	1 (0.8)
Hypokalemia	44 (33.6)	9 (6.9)
Peripheral edema	33 (25.2)	2(1.5)
Pleural effusion	4(3.1)	1 (0.8)

^*Grade 5 AEs reported in 5 (4%) patients and 2 additional deaths due to Grade 4 injury (motorcycle accident) and Grade 3 pneumonia. Six patients had a single serious AE (injury, pneumonia, aspiration pneumonia, myocardial infarction, congestive cardiac failure, and coronary artery disease). One patient had sepsis, pneumonia, and acute respiratory failure.

^**No Grade ≥4 events reported.