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Table 1 Demographics and baseline characteristics

From: A randomized, open-label, multi-center, active-controlled phase II study comparing abiraterone acetate tablets (II), an improved formulation, versus originator abiraterone acetate in patients with metastatic castration-resistant prostate cancer

 

AAT(II)

(N = 34)

OAA

(N = 34)

Total

(N = 68)

Age (year)

71.4 (6.4)

70.6 (7.9)

71.0 (7.1)

Height (cm)

166.9 (7.8)

166.9 (5.8)

166.9 (6.8)

Weight (kg)

69.1 (14.3)

67.5 (11.6)

68.3 (12.9)

BMI (kg/m2)

24.6 (3.5)

24.1 (3.3)

24.4 (3.3)

ECOG performance status, n (%)

 0

7 (20.6)

12 (35.3)

19 (27.9)

 1

27 (79.4)

22 (64.7)

49 (72.1)

Serum testosterone level (ng/dL)

11.3 (10.5)

9.5 (4.3)

10.4 (8.0)

PSA concentration (ng/mL)

119.5 (225.4)

435.7 (1423.0)

277.6 (1023.6)

Course of disease (month)a

30.9 (29.0)

28.4 (26.8)

29.6 (27.7)

Gleason score

8.3 (1.0)

8.3 (1.1)

8.3 (1.0)

Metastatic organ sites, n (%)

 1

18 (52.9)

22 (64,7)

40 (58.8)

 2

11 (32.4)

7 (20.6)

18 (26.5)

 3

1 (2.9)

3 (8.8)

4 (5.9)

 ≥ 4

4 (11.8)

2 (5.9)

6 (8.8)

Medical history, n (%)

 Hypertension

12 (35.3)

10 (29.4)

22 (32.4)

 Aortic atherosclerosis

3 (8.8)

1 (2.9)

4 (5.9)

 Alanine aminotransferase increased

1 (2.9)

1 (2.9)

2 (2.9)

 Aspartate aminotransferase increased

1 (2.9)

0

1 (1.5)

  1. Data are mean (SD) unless otherwise specified
  2. AAT(II) Abiraterone acetate tablets (II), OAA Originator abiraterone acetate, BMI Body mass index, ECOG Eastern Cooperative Oncology Group, PSA prostate-specific antigen, SD Standard deviation
  3. aCourse of disease (month) = (Date of signed informed consent – Date of first pathological diagnosis + 1) ✕ 12/365.25