Abiraterone Acetate: Package Insert and Label Information (Page 2 of 8)

COU-AA-301

Metastatic CRPC Following Chemotherapy

COU-AA-301 enrolled 1195 patients with metastatic CRPC who had received prior docetaxel chemotherapy. Patients were not eligible if AST and/or ALT ≥ 2.5 x ULN in the absence of liver metastases. Patients with liver metastases were excluded if AST and/or ALT > 5 x ULN.

Table 1 shows adverse reactions on the abiraterone acetate tablets arm in COU-AA-301 that occurred with a ≥ 2% absolute increase in frequency compared to placebo or were events of special interest. The median duration of treatment with abiraterone acetate tablets with prednisone was 8 months.

Table 1: Adverse Reactions due to Abiraterone Acetate Tablets in COU-AA-301
*
Adverse events graded according to CTCAE version 3.0.
Includes terms Arthritis, Arthralgia, Joint swelling, and Joint stiffness.
Includes terms Muscle spasms, Musculoskeletal pain, Myalgia, Musculoskeletal discomfort, and Musculoskeletal stiffness.
§
Includes terms Edema, Edema peripheral, Pitting edema, and Generalized edema.
Includes all fractures with the exception of pathological fracture.
#
Includes terms Arrhythmia, Tachycardia, Atrial fibrillation, Supraventricular tachycardia, Atrial tachycardia, Ventricular tachycardia, Atrial flutter, Bradycardia, Atrioventricular block complete, Conduction disorder, and Bradyarrhythmia.
Þ
Includes terms Angina pectoris, Chest pain, and Angina unstable. Myocardial infarction or ischemia occurred more commonly in the placebo arm than in the abiraterone acetate tablets arm (1.3% vs. 1.1% respectively).
ß
Includes terms Cardiac failure, Cardiac failure congestive, Left ventricular dysfunction, Cardiogenic shock, Cardiomegaly, Cardiomyopathy, and Ejection fraction decreased.

System/Organ Class

Abiraterone Acetate Tablets with Prednisone(N = 791)

Placebo with Prednisone

(N = 394)

All Grades *

Grade 3-4

All Grades

Grade 3-4

Adverse reaction

%

%

%

%

Musculoskeletal and connective tissue disorders

Joint swelling/discomfort

30

4.2

23

4.1

Muscle discomfort

26

3.0

23

2.3

General disorders

Edema §

27

1.9

18

0.8

Vascular disorders

Hot flush

19

0.3

17

0.3

Hypertension

8.5

1.3

6.9

0.3

Gastrointestinal disorders

Diarrhea

18

0.6

14

1.3

Dyspepsia

6.1

0

3.3

0

Infections and infestations

Urinary tract infection

12

2.1

7.1

0.5

Upper respiratory tract infection

5.4

0

2.5

0

Respiratory, thoracic and mediastinal disorders

Cough

11

0

7.6

0

Renal and urinary disorders

Urinary frequency

7.2

0.3

5.1

0.3

Nocturia

6.2

0

4.1

0

Injury, poisoning and procedural complications

Fractures

5.9

1.4

2.3

0

Cardiac disorders

Arrhythmia #

7.2

1.1

4.6

1.0

Chest pain or chest discomfort Þ

3.8

0.5

2.8

0

Cardiac failure ß

2.3

1.9

1.0

0.3

Table 2 shows laboratory abnormalities of interest from COU-AA-301.

Table 2: Laboratory Abnormalities of Interest in COU-AA-301

Abiraterone Acetate Tablets with Prednisone

(N = 791)

Placebo with Prednisone

(N = 394)

Laboratory Abnormality

All Grades (%)

Grade 3-4 (%)

All Grades (%)

Grade 3-4 (%)

Hypertriglyceridemia

63

0.4

53

0

High AST

31

2.1

36

1.5

Hypokalemia

28

5.3

20

1.0

Hypophosphatemia

24

7.2

16

5.8

High ALT

11

1.4

10

0.8

High Total Bilirubin

6.6

0.1

4.6

0

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