Abiraterone (Page 3 of 12)

Table 1: Adverse Reactions due to Abiraterone Acetate in COU-AA-301

Abiraterone Acetate with Prednisone (N=791)

Placebo with Prednisone (N=394)

System/Organ Class Adverse reaction All Grades 1 % Grade 3-4 % All Grades % Grade 3-4 %
Musculoskeletal and connective tissue disorders
Joint swelling/discomfort 2 30 4.2 23 4.1
Muscle discomfort 3 26 3.0 23 2.3
General disorders
Edema 4 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 5.9 1.4 2.3 0
Cardiac disorders
Arrhythmia 6 7.2 1.1 4.6 1.0
Chest pain or chest discomfort 7 3.8 0.5 2.8 0
Cardiac failure 8 2.3 1.9 1.0 0.3
1 Adverse events graded according to CTCAE version 3.0. 2 Includes terms Arthritis, Arthralgia, Joint swelling, and Joint stiffness. 3 Includes terms Muscle spasms, Musculoskeletal pain, Myalgia, Musculoskeletal discomfort, and Musculoskeletal stiffness. 4 Includes terms Edema, Edema peripheral, Pitting edema, and Generalized edema. 5 Includes all fractures with the exception of pathological fracture. 6 Includes terms Arrhythmia, Tachycardia, Atrial fibrillation, Supraventricular tachycardia, Atrial tachycardia, Ventricular tachycardia, Atrial flutter, Bradycardia, Atrioventricular block complete, Conduction disorder, and Bradyarrhythmia. 7 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 arm (1.3% vs. 1.1% respectively). 8 Includes terms Cardiac failure, Cardiac failure congestive, Left ventricular dysfunction, Cardiogenic shock, Cardiomegaly, Cardiomyopathy, and Ejection fraction decreased.

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

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

Abiraterone Acetate 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

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 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 with prednisone was 13.8 months.

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