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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