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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