Abiraterone Acetate (Page 4 of 11)

COU-AA-302

Metastatic CRPC Prior to Chemotherapy

COU-AA-302 enrolled 1088 patients with metastatic CRPC who had not received prior cytotoxic chemotherapy. Patients were ineligible if AST and/or ALT ≥ 2.5 x ULN and patients were excluded if they had liver metastases.

Table 3 shows adverse reactions on the abiraterone acetate tablets arm in COU-AA-302 that occurred in ≥ 5% of patients with a ≥ 2% absolute increase in frequency compared to placebo. The median duration of treatment with abiraterone acetate tablets with prednisone was 13.8 months.

Table 3: Adverse Reactions in ≥ 5% of Patients on the Abiraterone Acetate Tablets Arm in COU-AA-302
*
Adverse events graded according to CTCAE version 3.0.
Includes terms Edema peripheral, Pitting edema, and Generalized edema.
Includes terms Arthritis, Arthralgia, Joint swelling, and Joint stiffness.

System/Organ Class

Abiraterone Acetate Tablets with Prednisone

(N = 542)

Placebo with Prednisone

(N = 540)

All Grades *

Grade 3-4

All Grades

Grade 3-4

Adverse reaction

%

%

%

%

General disorders

Fatigue

39

2.2

34

1.7

Edema

25

0.4

21

1.1

Pyrexia

8.7

0.6

5.9

0.2

Musculoskeletal and connective tissue disorders

Joint swelling/discomfort

30

2.0

25

2.0

Groin pain

6.6

0.4

4.1

0.7

Gastrointestinal disorders

Constipation

23

0.4

19

0.6

Diarrhea

22

0.9

18

0.9

Dyspepsia

11

0.0

5.0

0.2

Vascular disorders

Hot flush

22

0.2

18

0.0

Hypertension

22

3.9

13

3.0

Respiratory, thoracic and mediastinal disorders

Cough

17

0.0

14

0.2

Dyspnea

12

2.4

9.6

0.9

Psychiatric disorders

Insomnia

14

0.2

11

0.0

Injury, poisoning and procedural complications

Contusion

13

0.0

9.1

0.0

Falls

5.9

0.0

3.3

0.0

Infections and infestations

Upper respiratory tract infection

13

0.0

8.0

0.0

Nasopharyngitis

11

0.0

8.1

0.0

Renal and urinary disorders

Hematuria

10

1.3

5.6

0.6

Skin and subcutaneous tissue disorders

Rash

8.1

0.0

3.7

0.0

Table 4 shows laboratory abnormalities that occurred in greater than 15% of patients, and more frequently (> 5%) in the abiraterone acetate tablets arm compared to placebo in COU-AA-302.

Table 4: Laboratory Abnormalities in > 15% of Patients in the Abiraterone Acetate Tablets Arm of COU-AA-302
*
Based on non-fasting blood draws

Abiraterone Acetate Tablets with Prednisone

(N = 542)

Placebo with Prednisone

(N = 540)

Laboratory Abnormality

Grade 1-4 %

Grade 3-4 %

Grade 1-4 %

Grade 3-4 %

Hematology

Lymphopenia

38

8.7

32

7.4

Chemistry

Hyperglycemia *

57

6.5

51

5.2

High ALT

42

6.1

29

0.7

High AST

37

3.1

29

1.1

Hypernatremia

33

0.4

25

0.2

Hypokalemia

17

2.8

10

1.7

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