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.
| 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.
| ||||
| 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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