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|
|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|
|Renal and urinary disorders|
|Injury, poisoning and procedural complications|
|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
Placebo with Prednisone
|Laboratory Abnormality||All Grades (%)||Grade 3-4(%)||All Grades (%)||Grade 3-4 (%)|
|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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