Abiraterone (Page 4 of 12)
Table 3: Adverse Reactions in ≥5% of Patients on the Abiraterone Acetate Arm in COU-AA-302
| Abiraterone Acetate with Prednisone (N=542) | Placebo with Prednisone (N=540) | |||
| System/Organ Class Adverse reaction | All Grades 1 % | Grade 3-4 % | All Grades % | Grade 3-4 % |
| General disorders | ||||
| Fatigue | 39 | 2.2 | 34 | 1.7 |
| Edema 2 | 25 | 0.4 | 21 | 1.1 |
| Pyrexia | 8.7 | 0.6 | 5.9 | 0.2 |
| Musculoskeletal and connective tissue disorders | ||||
| Joint swelling/discomfort 3 | 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 |
| 1 Adverse events graded according to CTCAE version 3.0. 2 Includes terms Edema peripheral, Pitting edema, and Generalized edema. 3 Includes terms Arthritis, Arthralgia, Joint swelling, and Joint stiffness. | ||||
Table 4 shows laboratory abnormalities that occurred in greater than 15% of patients, and more frequently (>5%) in the abiraterone acetate arm compared to placebo in COU-AA-302.
Table 4: Laboratory Abnormalities in >15% of Patients in the Abiraterone Acetate Arm of COU-AA-302
| Abiraterone Acetate 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 1 | 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 |
| 1 Based on non-fasting blood draws | ||||
LATITUDE: Patients with Metastatic High-risk CSPC
LATITUDE enrolled 1199 patients with newly-diagnosed metastatic, high-risk CSPC who had not received prior cytotoxic chemotherapy. Patients were ineligible if AST and/or ALT ≥2.5 x ULN or if they had liver metastases. All the patients received GnRH analogs or had prior bilateral orchiectomy during the trial. The median duration of treatment with abiraterone acetate and prednisone was 24 months. Table 5 shows adverse reactions on the abiraterone acetate arm that occurred in ≥5% of patients with a ≥2% absolute increase in frequency compared to those on the placebos arm.
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